ENIGMA DENTURE TEETH

K984128 · Davis Schottlander & Davis, Ltd. · ELM · Feb 9, 1999 · Dental

Device Facts

• Record ID: K984128
• Device Name: ENIGMA DENTURE TEETH
• Applicant: Davis Schottlander & Davis, Ltd.
• Product Code: ELM · Dental
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2

Intended Use

ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Device Story

Enigma Denture Teeth are prosthetic dental components used by dental professionals (DDS/DMD) to construct full or partial dentures. The teeth are integrated with denture base resin to restore patient dentition. The device is a passive prosthetic component; it does not involve electronic inputs, software, or automated processing. It is used in a clinical or laboratory setting to improve patient oral function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Prosthetic denture teeth for integration with denture base resin. Passive mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for use in the construction of full and partial dentures by dental professionals (DDS/DMD). Not for OTC use.

Regulatory Classification

Identification

A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Davis Schottlander & Davis, Ltd. C/O Mr. Clyde E. Ingersoll CEI Enterprises 54 Riverview Avenue Tonawanda, New York 14150-5260

Re : K984128 Trade Name: Enigma Denture Teeth Regulatory Class: II Product Code: ELM Dated: January 26, 1999 Received: January 26, 1999

Dear Mr. Ingersoll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ್ಷ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Ingersoll

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration Chercrea) : 1255 andrig II Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours;

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Davis Schottlander & Davis Ltd

Dunhams Lane, Letchworth, Herts SG6 1NS, England +044 (0)1462 480848 Phone: [phone] FAX:

### 510 (k)

## ATTACHMENT #4

## Schottlander ENIGMA denture teeth

#### INDICATIONS FOR USE

Device Name: Schottlander ENIGMA denture teeth

ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures.

For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Davis Schottlander & Davis Ltd

Lccade.

Mohamed K Ladha Quality Assurance manager

Susan Raap

(Division Sign (Division) Division of Deata), tefection Control, and General Hospital Devices 510(k) Number

PRESCRIPTION DEVICE (Rx)