POLY SILOXANE IMPRESSION MATERIAL

K053018 · Millennium Dental International, Inc. · ELW · Nov 8, 2005 · Dental

Device Facts

• Record ID: K053018
• Device Name: POLY SILOXANE IMPRESSION MATERIAL
• Applicant: Millennium Dental International, Inc.
• Product Code: ELW · Dental
• Decision Date: Nov 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Story

Poly siloxane impression material used by dental professionals to capture accurate anatomical impressions of patient teeth and gums. Material placed intraorally or on preformed impression trays; sets to form a negative mold of dental structures. Used by dentists to facilitate fabrication of dental restorations, prosthetics, or orthodontic appliances. Benefits include high dimensional accuracy and detail reproduction for clinical dental procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Poly siloxane-based dental impression material. Class II device (21 CFR 872.3660).

Indications for Use

Indicated for use in patients requiring dental impressions to reproduce the structure of teeth and gums.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

NOV - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanette Smith Operations Manager Millennium Dental International, Incorporated 1980 Hyde Park Road London, Ontario, N6H5L9 CANADA

Re: K053018

Trade/Device Name: Multiple (POLY Siloxane Impression Material) Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: October 18, 2005 Received: October 26, 2005

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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IUM DENTAL INTERNATIONAL, INC. ihmission: tiple-POLY SILOXANE IMPRESSION MATERIAL

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| Indications for Use | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | MILLENNIUM DENTAL INTERNATIONAL. INC. |
| 510(k) Number (if known): | K053018 |
| Device Name: | Multiple (POLY SILOXANE IMPRESSION<br>MATERIAL) |
| Indications for Use: | Device intended to be placed intraorally or on a preformed<br>impression tray and used to reproduce the structure of a<br>patient's teeth and gums. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ ×

OR (Per 21 CFR 801.109) Over-the-Counter Use__________

(Optional Format 1-2-96)

RSBetz005 for Dr Susan Lunner

nesthesion Infection Control. De

510(k) Number: K053018

1120 Federal Road • Brookfield, CT 06804