Patterson Dental Supply, Inc. — Hazardous Materials Safety Interpretation

Page 1S. Departmel Transportatio 400 Seventh Street, S.W. Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration DEC 15 2005 Mr. Robb Boros Ref. No. 05-0272 1905 Lakewood Drive Patterson Dental Supply, Inc. Boone, IA 50036 Dear Mr. Boros: This is in response to your October 27, 2005 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if a specially packaged bonding solution meeting the definition of a Class 3 flammable liquid in Packing Group Il is subject to the HMR. According to your letter, your company intends to distribute promotional samples of a bonding solution. Each sample consists of one capsule, with a total volume of 0.1 ml further packaged in foil. The capsule must be opened with a counter-clockwise twist of the cap and an applicator is used to retrieve the solution. You further state that liquid did not flow from the capsule when the cap was removed, and the capsule was inverted. Although the capsule contains a small amount of a flammable liquid, it is our opinion that the packaging procedures and methods you use for shipment of the promotional samples mitigate the minimal hazard that may be present during transportation. Therefore, in accordance with § 173.120(d), samples of the bonding solution that are packaged as described above are not subject to regulation under the HMR. I hope tlis information is helpful. Please contact us if you require additional assistance. Sincerely, Press Chief, Standards Development Office of Hazardous Materials Standards 173-120(d) 050272#

Page 2OCT-27-2005 THU 11:33 AM PATTERSON DENTAL SUPPLY FAX NO. 515 433 1701 P. 02 heary BY PATTERSON DANTA SI Prid §173.120(d) Definitions 05-0212 Dear Ms. LeValle October 27, 2005 As provided by 49 CFR 173.120(d) I am requesting a determination that the device presented herein is not subject to the Hazardous Materials Regulations. The material in question is a Class 3 PGII Mammable liquid packaged in a black capsule and urther packed in a foil (Appendix A). The total volume per capsule is 0.1ml. The capsule is pened with an anti-clockwise twist of the cap (Appendix B). When the cap is removed, one ot the green applicators is used to retrieve the bonding solution. When the cap is removed and the capsule inverted, the liquid did not flow from the capsule. Appendix A shows the contents of the sample package we intend to send to customers. There is & sellable version of this product that contains 50 of the black capsules packaged the same as in the sample below I have coded to ship as a consumer commodity request. This item is sampling of a new product and my company was scheduled to start a 1 am very aware of the normal time frame required to receive, review and respond to this type of promotion using these samples on October 26, 2005. Upon discovering that the bonding chemical is hazardous, we've delayed the shipping of the samples in order to find a practical means to package them. Sending such samples as ORM or under the 173.4 exception is impracticable. These samples are the focal point of a dated promotional offer to existing customers. Any assistance to expedite a response would be greatly appreciated. If there are any questions or additional information is required, please contact me at 515.433.1700 or on my cell phone at 515.230.0337. Thank you for all your assistance in this matter. Sincerely, Robb Boros Compliance Coordinator Patterson Companies, Inc Contral Distribution Center 1905 LAKEWoOD DRIve • BooNE, IA 50036 - PHONI: (515) 433-1700 • Fax (515) 433-1701 An Employce Owned Company#

Page 3OCT-27-2005 THU 11:33 AM PATTERSON DENTAL SUPPLY FAX NO. 515 433 1701 P. 03 Appendix A Free Sample-Not For Resale G-BOND™ Unit Dose ONE COMPONENT SELF-ETCHING LIGHT-CURED ADHESIVE For use only by a dental professional in the recommended indications. DISTRIBUTED by GC AMERICA INC. 3737 West 127th Street Alsip, Illinois 60803 U.S.A. MANUFACTURED IN JAPAN G-BOND" ENT BELT ETCHAK Unit Dose : STORAGE G-BOND™ Unit Dos 0.1mL *GC.#

Page 4OCT-27-2005 THU 11:33 AM PATTERSON DENTAL SUPPLY FAX NO. 515 433 1701 P. 04 Appendix B CAPSULE#

Page 5MS002277 - G-BOND Page 1 of 2 Better Quality, KElushmac opy. АHH-20 MATERIAL SAFETY DATA SHEET 12/8/05 SECTION 1 - SOURCE/IDENTITY/USE INFORMATION COMMON NAME: CHEMICAL NAME: N.A G-BOND PRODUCT USE: Light-cure bonding agent. The following information is provided with regard to the toxicity and hazards the pure components present in this product. SECTION 2 - HAZARDOUS INGREDIENTS/IDENTITY INFORMATION COMPONENT Acetone 67-64-1 C.A.S. EXPOSURE LIMITS TWA=750ppm LD50/LC50 N.E. 40% % (OSHA, ACGIH) (OSHA. ACGIH) STEL=1000ppm Distilled water 7732-18-5 N.E. N.E. 20% anhydride 4-Methacryloxyethyltrimellitate 70293-55-9 N.E. N.E. 15% Triethyleneglycol dimethacrylate Urethane dimethacrylate 72869-86-4 109-16-0 N.E. N.E. N.E. N.E. 10% 9% SECTION 3 - PHYSICAL/CHEMICAL PROPERTIES BOILING POINT: 55°C SPECIFIC GRAVITY: N.E. VAPOR PRESSURE: N.E. MELTING POINT: N.E. VAPOR DENSITY: N.E. EVAPORATION RATE: N.E. SOLUBILITY IN WATER: Miscible COEFFICIENT OF OILWATER DISTRIBUTION: N.E. ODOR THRESHOLD: N.E. APPEARANCE AND ODOR: light yellow liquid; slight ester-like odor SECTION 4 - FIRE AND EXPLOSION DATA FLASH POINT: - 19°C (Acetone) EXTINGUISHING MEDIA: Chemical foam, carbon dioxide and dry chemical. FLAMMABLE LIMITS: LEL 2.5, L'EL 13 SPECIAL FIRE FIGHTING PROCEDURES: Wear self-contained breathing apparatus in case of fire. UNUSUAL FIRE AND EXPLOSION HAZARDS: Product is not explosive; however, formation of explosive air/vapor mixtures are possible. HAZARDOUS COMBUSTION PRODUCTS: Formation of toxic gases is possible in case of fire. SECTION 5 - REACTIVITY DATA STABILITY: Stable X POLYMERIZATION: Will Not Occur [X Will Occur Unstable CONDITIONS TO AVOID: Avoid high heat and humidity. INCOMPATIBILITY (Materials to Avoid): None. HAZARDOUS DECOMPOSITION OR BY-PRODUCTS: No dangerous decomposition products known.#

Page 6MS002277 - G-BOND Page 2 of 2 SECTION 6 - HEALTH HAZARD DATA and FIRST AID INFORMATION YES MUTAGENIC AFFECTS NO NE NA NTP TARC OSHA OTHER X TERATOGENIC AFFECTS REPRODUCTIVE TOXIN X SENSITIZER CARCINOGENICITY X X ROUTES OF ENTRY: SECTION 6 - HEALTH HAZARD DATA and FIRST AID INFORMATION - continued Inhalation X Skin x Ingestion x HEALTH HAZARD (Acute and Chronic): Irritant to skin, mucous membranes, eyes, and respiratory tract. SIGNS AND SYMPTOMS OF OVEREXPOSURE: N.E. CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE: N.E. EMERGENCY FIRST AID PROCEDURES: INHALATION: Supply fresh air. Seek medical attention if irritation develops. attention. EYE CONTACT: Flush eyes with plenty of water for at least 15 minutes. If symptoms persist, seek medical SKIN CONTACT: Immediately wash with soap and water and rinse thoroughly. Seek medical attention if irritation develops. INGESTION: If irritation develops, seek medical attention. SECTION 7 - PRECAUTIONS FOR SAFE HANDLING AND USE IN CASE OF RELEASE OR SPILL: Absorb with inert material and place in a chemical waste container. WASTE DISPOSAL METHOD: Dispose of in accordance with local, state and federal guidelines. STORAGE, HANDLING, AND SPECIAL PRECAUTIONS: Store in cool, dry conditions in well sealed containers. SECTION 8 - CONTROL MEASURES or longer exposure use self-contained respiratory protective device. RESPIRATORY PROTECTION: In case of brief exposure or low pollution use respiratory filter device. In case of intensive VENTILATION: Local Exhaust X Mechanical: Special: Other: PROTECTIVE GLOVES: Recommended. OTHER PROTECTIVE CLOTHING OR EQUIPMENT: N.A. EYE PROTECTION: Tightly sealed goggles recommended. WORK/HYGIENIC PRACTICE: Observe good hygienic work practices. SECTION 9 - PREPARATION INFORMATION This data is supplied to comply with OSHA Hazard Communication Standard 29 CFR 1910,1200 and W.H.M.I.S. CPR. PREPARED BY: T. Joritz DATE: 21 March 2005 Director Regulatory Affairs N.E. = NOT ESTABLISHED N.A. = NOT APPLICABLE The information herein is given in good faith but no warranty expressed or implied is made. FIRE - 4 TOXICITY - 2 NFPA REACTIVITY - 1 SPECIAL -#

Page 7OCT-27-2005 THU 11:33 AM PATTERSON DENTAL SUPPLY FAX NO. 515 433 1701 P. 05 NIS002277 G-BOND MATERIAL SAFETY DATA SEKET Puge 1 of 2 BEGTON 1 - SOURCE ADAN TWUSE INFORMATION GC AMERICA INC. DISTREUTOR 3737 West. 1270a St. Telephons: 708-597-0800 Alrip, Ilinois, 60B03 Por Juality peter Hour: Nog.- Fri. 8:00 am. - 5:00 pm. C.S.T. Iresportation Emergency No. 800-124-9300 12/08/05 CHEMICAL NAME: NA. COMMON NAME: G-BOND PRODUCT USE: Light-cure bonding necut. SECTION 2 - HAZARDOUS INGREDLENTS DENARY IMPORMATIO we or I provide with renare so the tansit and haands is guns componass presus du this produc COMPONENT 24célontè 67-54-1 Cas. EXPOSURE LiNTIS (OSHA, ACGUE) THA=750ppm NE 4094 STEL=1000ppta Distilled water 4-Merhncry doryntly trimellitate 7732-18-5 70293-55-9 N.E NE N.E. 20% Truthane dimechacaylate anbrydride 15% Trietylence cal dimcfacıylare T2860-864 109-16-0 NE 10-20% 10% SECTION 3 - PHYSICAL CHEMICAL PROPLRTEES VAPOR PRESSURE: BOILING POINT: 55°C SPECIFIC GRAVITY: VAPOR DENSITY: NE MELTING PORT: NE SOLUBILITY IN WATER: MiSCENe NE. DOOR THRESHOLD: EVAPORATION RATE: NE COEFFICIENT OF OILIATER DISTRIBUTION: N.E. APPEARANCE AND ODDR: lph yallow liquid; slightt eat-like udar N.E. SECTION • • FIRE AND EXPLOSION DATA EXTINGUISHING MEDIA: Chemical fouza, carbon dioxide and dry chemical. FLASH POINT: -10°C FLAMMABLE LIMITS: LEL 2.5, UEL 13 UNUSUAL FIRE AND EXPLOSION HAZARDS: Product is not caploiive; bowever, forwation of explosive sinvupor mixtures SPECIAL FIRE FIGHTING PROCEDURE: Wehr solf-bootained bresthing appantua in cuse of fora. HAZARDOUS COMBUSTION PRODUCTS: Formation of taxic gases fa poesible in case of for. aro possible. SECTOR ES REACTIVITY DATA STABILITY: POLYMERIZATION: Will Not Occur 181 Grabho X natabia L i Docur I COMPATIBILITY Matoria to Avail: Nous. CONDITONS TO AVOID: Avoid high heat and humidity. HAZARDOUS DECOMPOSITION OR BY-PRODUCTS: Na dangerous decomposition product norn.#

Page 8OCT-27-2005 THU 11:33 AM PATTERSON DENTAL SUPPLY FAX NO. 515 433 1701 P. 06 MS002277 G-BOND Page 2062 SECTION GREALINEAD a FARST ALPIN ORMATION MUTAGENIC APPECTS YES NO - NE - НТР TARG OTHER TERATOGENIC AFFECTS CARCINOGENICITY REPRODUCTIVE TOXIN SENSITIZER X ROUTES OF ENTRY: HEALTH HAZARD (Acute and Chroniel: Irritant to sita, macon memtrancs, ones, and respiratory tract. CONNITIONS GENERALLY AGGRAVATED BY EXPOSURE: NE. SIGNS AND SYMPTOMS OF OVEREXPOSURE: NE EMERGENCY FIRST A/D PROCEDURES: INHALATIOW: Supply fresh air. Sock medical atention if inricatico devalps. SKIN CONTACT: Immediasly wash with soap and wales and rinse thoroughly. Seek medical attornion if imitation EYE CONTACT: Flush ayes with plenty af water for at least 15 minutes. Ifsymptoms parist, sack medical attentics. INGESTION: Er iritation clevelopa, ansk medical assention. dewclopa. SECION? - PRECAUTIONS FOR SAFE HANDLING AND USE IN CASE DF RELEASE OR SPILL: Absorb with inert material and place in a chemical waste container. TORAGE, HANDLING, AND SPECIL PRECAUTIONS: Store im apol, dry conditiona in well sculed continer VASTE DISPOSAL METHOD: Disposo of to accordance with local, state and fedesal guidelines SECTION 8 - CONTROL MEASURES RESPIRATORY PROTECTION: la cuss of briel oxposure a low pollution use reppirory filter device. In case of intaive ou longer exporuro use self-contained, reapiratory protectiva devio. VENTILATION: Local Exhaust ai Mechanical: Порося 0J Deber: LI EYE PROTECTON: Tighily scalad goggles commanded. PROTECTIVE GLOVES: Rocommended. WORKIHYGIENIC PRACTICE: Discus good hygienic mock practices. OTHER PROTECTIVE CLOTHING OR EQLIPMENT: NA. SECTION D. PREPARATION INFORMATEON The see is seppis so cony with OSHA taand Communicano Stamerd 29 CF 19101200 a FEARS CN PREPARED BY: I. Inniz Dinctor Regulatory Affaire DATE: 20 Isly 2004 A.A. - NOT APPLICARLE NE • NOT ESTABLISHED Tus kurturariar herein is grom in good faish bee no maraur expressed or implied is marie. FIRE -4 NFPA REACTVITY T SPECIAL-#