BITEM LOCK, MODELS SW006, SW012 by THERMOELASTIC TECHNOLOGIES, INC.

The BITEM LOCK product is a thermo-adjustable alignment bracket with the same use as the predicate device. The only difference is the predicate device is Made from metal and this device is a thermo-adjustable material. 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.

AI/ML Overview

This document, an FDA 510(k) Summary for the BITEM LOCK orthodontic appliance, does not contain information related to acceptance criteria, a study proving device performance against such criteria, or any details about software algorithm performance.

The provided text focuses on:

Device identification: Trade name, classification, submitter, and contact information.
Predicate device comparison: Highlighting the BITEM LOCK's similarity in intended use and application to the predicate device (K900678 Myloc System Winder Research). The key difference noted is the material (thermo-adjustable vs. metal) and method of securing it.
Intended use: Clearly stating its application as an alignment bracket for removable dentures and to aid in securing dentures.
FDA determination: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or MCRM/standalone study details because this content is not present in the provided text. The device described is a physical orthodontic appliance, not a software or AI-based medical device.

Summary

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MAR 14 2000	510(K) SUMMARY(as required by 807.92(c))
Submitter of 510(k):	Regulatory & Marketing Services, Inc. (RMS)3234 Ella LaneNew Port Richey, FL 34655
	Phone: 813-645-2855Fax: 813-645-2856
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/Comparison:	The BITEM LOCK product is a thermo-adjustablealignment bracket with the same use as the predicatedevice. The only difference is the predicate device isMade from metal and this device is a thermo-adjustable material.
Intended Use:	For use as an alignment bracket for removabledentures, 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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	✓	OR	Over-The-Counter Use
(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)
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Regulation Number and Section

§ 872.5410 Orthodontic appliance and accessories.

(a)
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.(b)
Classification. Class I (general 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.