(78 days)
Not Found
No
The summary describes a physical dental bracket made of thermo-adjustable material and explicitly states no mention of AI, DNN, or ML.
No.
The device is described as an "aligning bracket for removable dentures" and aids in "securing dentures," functioning primarily as a mechanical aid for dental prosthetics rather than directly treating or preventing a disease or condition. Its purpose is structural support and alignment.
No
The device is described as an "aligning bracket" for dentures, used to aid in securing them. Its function is mechanical support/alignment, not detection or diagnosis of a condition.
No
The device description clearly states it is a "thermo-adjustable alignment bracket" made from physical materials (methacrylate liquid, phthalate plasticizer, EGDMA cross linker, and polymer powder), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aligning bracket for removable dentures, and to aid in securing dentures." This describes a device used mechanically within the mouth to support and align dentures.
- Device Description: The description details a "thermo-adjustable alignment bracket" made from specific materials. This is a physical device for mechanical function.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening.
The device's function is purely mechanical and related to the physical placement and securing of dentures, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
For use as an alignment bracket for removable dentures, and to aid in securing dentures.
Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.
Product codes
EJF
Device Description
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 BITEM LOCK product is fundamentally similar to the predicate device.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K900678 Myloc System Winder Research
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| MAR 14 2000 | 510(K) SUMMARY
(as required by 807.92(c)) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)
3234 Ella Lane
New Port Richey, FL 34655 |
| | Phone: 813-645-2855
Fax: 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-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. |
| Intended Use: | For use as an alignment bracket for removable
dentures, and to aid in securing dentures. |
1
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.
2
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.
3
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
4
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) |
|---|---|---|
| --------------- | --------- | -------------------------- |