MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)

{0}------------------------------------------------ #### Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for A-Silicone Page 12 of 15 JUN 1 7 2004 # 510(k) SUMMARY As required by the Safe Medical Devices Act of 1990 ### A-SILICONE ## IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES Bisco TWINZ VPS Heraeus Kulzer FLEXITIME The two indicated predicate devices are addition reaction silicone impression materials also known as vinyl polysiloxane impression materials. The viscosity range is similar to A-SILICONE in that they contain examples of putty based, heavy body, medium body and light body products intended for identical uses in dentistry, that is, for taking impressions of teeth, prepared teeth, oral soft tissue, and bite registrations. | | Cosmedent<br>A-SILICONE | Heraeus Kulzer<br>FLEXITIME1-2 | Bisco<br>TWINZ VPS3-4 | |------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Intended Use | Auto-mix,<br>elastomeric dental<br>impression<br>material | Auto-mix,<br>elastomeric dental<br>impression<br>material | Auto-mix,<br>elastomeric dental<br>impression<br>material | | Composition | Addition reaction,<br>silica filled<br>polydimethyl<br>siloxane | Addition reaction,<br>silica filled<br>polydimethyl<br>siloxane | Addition reaction,<br>silica filled<br>polydimethyl<br>siloxane | | Clinical properties | Multiple<br>viscosities<br>permitting dual-<br>mix, monophase,<br>and putty-wash<br>techniques | Multiple<br>viscosities<br>permitting dual-<br>mix, monophase,<br>and putty-wash<br>techniques | Multiple<br>viscosities<br>permitting dual-<br>mix, monophase,<br>and putty-wash<br>techniques | | Viscosities or grades<br>available | Putty, heavy body,<br>medium body, and<br>light body | Putty, Heavy<br>body, medium<br>body, and<br>corrective light<br>body | Putty, heavy<br>body, medium<br>body, light body,<br>and extra light<br>body | #### SUBSTANTIAL EQUIVALENCE Summary {1}------------------------------------------------ # A-SILICONE 510(k) SUMMARY (cont) ### DESCRIPTION OF THE APPLICANT DEVICE - A-SILICONE A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques. | PROPERTY | Putty | Heavy Body | Medium<br>Body | Light<br>Body | |--------------------------------------|--------------------------|----------------------|-----------------------|----------------------| | Consistency, ISO 4823 | heavy body<br>type 0 | heavy body<br>type 1 | Medium body<br>type 2 | Light body<br>type 3 | | Color | light green | turquoise | lilac | pink | | Working time including<br>mixing | 45 seconds to one minute | | | | | Time in the mouth | two minutes | | | | | Total setting time,<br>minimum | 2 minutes - 45 seconds | | | | | Strain in compression, % | <2 | <4 | <5 | <5 | | Recovery from<br>deformation, % | >99.4 | >99.4 | >99.6 | >99.6 | | Linear dimensional change,<br>%, max | 0.2 | 0.15 | 0.15 | 0.15 | | Hardness Shore A | 70 | 50 | 45 | 40 | #### MATERIALS SPECIFICATIONS # INTENDED USES OF THE APPLICANT DEVICE - A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums. - A-SILICONE is also intended to be used as a bite registration or occlusal registration . material. Jami K. Sanchez James L. Sandrik, Ph.D. Cosmedent, Inc. Suite 2500 401 N. Michigan Ave. Chicago, Illinois 60611 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized lines representing the wings or body. JUN 1 7 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service Dr. James L. Sandrik Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611 Re: K041229 Trade/Device Name: Multiple (A-Silicone) Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 7, 2004 Received: May 10, 2004 Dear Dr. Sandrik: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becareermined the device is substantially equivalent (for the icitications for use stated in the enclosure) to legally marketed predicate devices marketed in multions for asso states in May 28, 1976, the enactment date of the Medical Device Interstate commerce prior st hat have been reclassified in accordance with the provisions of Amendinents, or to ac nove aller metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rist stion, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classinod (oos aboutional controls. Existing major regulations affecting (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register. {3}------------------------------------------------ #### Page 2 -Dr. Sandrik Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 12 a determination that your device complies with other requirements modi that I Dri may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal states requirements, including, but not limited to: registration r ou must comply Will and 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF rear 807), and iity systems (QS) regulation (21 CFR Part 820); and if requirements us set form in artistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse obger finding of substantial equivalence of your device to a premarket notification. - The Pore results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 5 of 15 # INDICATIONS FOR USE 510(k) Number (if known): KO41229 Device Name: MULTIPLE (A-SILICONE) Indication For Use: - A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums. - A-SILICONE is also intended to be used as a bite registration or occlusal registration . material. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: KO41083