CURATIVE DENTAL ACRYLIC TEETH

K060720 · Curative, LLC · ELM · Aug 25, 2006 · Dental

Device Facts

• Record ID: K060720
• Device Name: CURATIVE DENTAL ACRYLIC TEETH
• Applicant: Curative, LLC
• Product Code: ELM · Dental
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.

Device Story

Curative Dental Acrylic Teeth are preformed plastic denture teeth used by dental professionals to construct dentures. These devices serve as the functional and aesthetic components of a denture prosthesis. They are fabricated from acrylic materials and are intended to replace missing natural teeth. The device is used in a clinical or laboratory setting by dentists or dental technicians during the fabrication of removable dentures. The output is a physical prosthetic component that restores masticatory function and aesthetics for the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Preformed plastic denture teeth composed of acrylic resin. Device is a passive prosthetic component. No energy source, software, or connectivity features.

Indications for Use

Indicated for use as replacement teeth in dentures for patients requiring prosthetic dental restoration.

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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K060720

AUG 2 5 2006

# 510(k) Premarket Notification for the Curative Dental Acrylic Teeth

### COMPANY NAME AND ADDRESS 1.

#### Sponsor 1.1

Curative, LLC 2275 East Bayshore Road, Suite 105 Palo Alto, CA 94303 Telephone: [phone] Facsimile: 650-856-9601

### 1.2 Manufacturer

Shanghai Dental Materials Factory Shanghai Medical Instruments Co., Ltd No. 690 Tian Tong An Road Shanghai, China, 200081 Telephone: [phone] Facsimile: 86-21-65402339

### 1.3 Consultant/Contact

Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

| Primary Contact: | James R. Veale |
|------------------|----------------|
| Telephone: | 719-495-3438 |
| Facsimile: | 719-495-3438 |

### 2. DEVICE NAME

| Proprietary Name: | Curative Dental Acrylic Teeth |
|----------------------|--------------------------------------------------|
| Common/Usual Name: | Acrylic Denture Teeth |
| Classification Name: | Preformed plastic denture tooth (21CFR 872.3590) |

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## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Curative Dental Acrylic Teeth are intended for the same purpose as the predicate products, and are made of the same or similar materials.

#### PERFORMANCE TESTING 7.

Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2006

Curative, LLC C/O Mr. James R. Veale Senior Technical Adviser Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K060720

Trade/Device Name: Curative Dental Acrylic Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: July 27, 2006 Received: July 28, 2006

Dcar Mr. Veale:

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 – Mr. Veale

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 your 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,

Clive

Chin-Lin, Ph.D.

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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510(k) Number:

1060720

Device Name: Curative Dental Acrylic Teeth

Indications For Use:

Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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