BITEM LOCK, MODELS SW006, SW012

K994357 · Thermoelastic Technologies, Inc. · EJF · Mar 14, 2000 · Dental

Device Facts

• Record ID: K994357
• Device Name: BITEM LOCK, MODELS SW006, SW012
• Applicant: Thermoelastic Technologies, Inc.
• Product Code: EJF · Dental
• Decision Date: Mar 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5410
• Device Class: Class 1

Indications for Use

Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.

Device Story

BITEM LOCK is a thermo-adjustable alignment bracket for removable dentures. It functions as a mechanical aid to secure dentures within the oral cavity. The device is intended for clinical application by dental professionals. Unlike metal-based predicate devices, BITEM LOCK is composed of thermo-elastic acrylic materials, which are secured using either self-cure or heat-cure methods. The device provides a stable interface for denture alignment, assisting in the retention and positioning of the prosthesis for the patient.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use.

Technological Characteristics

Thermo-adjustable alignment bracket. Materials: methacrylate liquid, phthalate plasticizer, EGDMA cross-linker, and polymer powder. Application: secured via self-cure or heat-cure thermo-elastic acrylic. Form factor: ready-made for clinical application. No software or electronic components.

Indications for Use

Indicated for use as an aligning bracket for removable dentures and to aid in securing dentures in patients requiring dental prosthetic stabilization.

Regulatory Classification

Identification

An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

Predicate Devices

• Myloc System Winder Research (K900678)

Submission Summary (Full Text)

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| MAR 14 2000 | 510(K) SUMMARY<br>(as required by 807.92(c)) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)<br>3234 Ella Lane<br>New Port Richey, FL 34655 |
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Art Ward |
| Date of Summary: | November 26, 1999 |
| Trade Name: | BITEM LOCK |
| Classification Name: | Orthodontic Appliance or Accessory |
| Predicate Device: | K900678 Myloc System Winder Research |
| Device Description/<br>Comparison: | The BITEM LOCK product is a thermo-adjustable<br>alignment bracket with the same use as the predicate<br>device. The only difference is the predicate device is<br>Made from metal and this device is a thermo-<br>adjustable material. |
| Intended Use: | For use as an alignment bracket for removable<br>dentures, and to aid in securing dentures. |

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K 99435 7

## 510(K) Summary Differences and Similarities

The BITEM LOCK product is fundamentally similar to the predicate device.

Intended Use:

Both BITEM LOCK and the predicate device have the same intended use.

Applications:

Both products are used in the same dental applications and are used within the same type of dental facility.

Technological Characteristics:

These products are different in material compounds and method of preparation and application with the clinician. The base materials for the BITEM LOCK include a methacrylate liquid, a phthalate plasticizer, an EGDMA cross linker and polymer powder. They are ready made for clinical application. The predicate device is aluminum and is secured by a spring sleeve and beading wax . The BITEM LOCK is secured with either a self or heat cure thermo-elastic acrylic.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 4 2000

ThermoElastic Technologies, Incorporated C/O Mr. Art J. Ward Medical Device Consultant Requlatory and Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655

Re : K994357 BITEM LOCK, Models SW006, SW012 Trade Name: Requlatory Class: I Product Code: EJF December 1, 1999 Dated: December 27, 1999 Received:

Dear Mr. Ward:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ward

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 yitro 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 premarket notification" (21 CFR 807.97). 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

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ThermoElastic Technologies Inc .- BITEM LOCKS ...... Device Name:

Indications For Use:

Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-decoration: underline;">✓</div> | OR | Over-The-Counter Use | <div style="text-decoration: underline;"></div> |
|----------------------|--------------------------------------------------|----|----------------------|-------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |

Susan Bunga

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | K994337 | (Optional Format 1-2-96) |
|---------------|---------|--------------------------|
|---------------|---------|--------------------------|