(84 days)
Not Found
No
The summary describes a dental adhesive system and its components, with no mention of AI or ML technology.
No
The device is described as an adhesive system used in dental restorations and does not indicate a therapeutic intent beyond bonding and sealing dentinal tubules to reduce sensitivity, which is a structural rather than therapeutic function.
No
The device description and intended use indicate that Adhere is an adhesive system used for bonding restorative materials to tooth structure, sealing dentinal tubules, and reducing sensitivity. These are therapeutic or restorative functions, not diagnostic ones. There is no mention of identifying, detecting, or measuring a medical condition or disease.
No
The device description explicitly states it consists of physical components like surface conditioners, primers, adhesive resin, initiators, and accessories, which are not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Device's Intended Use: The intended use of "Adhere" is to promote bonding of restorative materials to tooth structure, seal dentinal tubules, reduce sensitivity, and bond composite repairs. These are all procedures performed directly on the patient's tooth within the oral cavity.
- Device Description: The description details a system of surface conditioners, primers, and adhesive resins applied to tooth surfaces. This is a direct application to the patient's anatomy, not an examination of a specimen outside the body.
The device is clearly intended for direct clinical use in dentistry, not for laboratory testing of human specimens.
N/A
Intended Use / Indications for Use
Adhere is used to bond restorative materials to enamel and dentin. The materials include composites, compomers, amalgam, ceramic veneers and ceramic inlays. In addition, Adhere is used to seal dentin, and reduce tooth sensitivity in non-bacterial mediated cervical lesions of teeth. Adhere is also used to promote composite bonds to ceramics and metals.
- to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
- to seal dentinal tubules
- to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
- to promote bonds between incremental layers of composite resins when building a composite restoration
- to bond composite resins repairs to ceramics and metals
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin, tooth structure, teeth
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K923546, K910860, K945604, 896659
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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K99283Y
NOV 1 5 1999
5612 Glenwood Road • Bethesda, MD • 20817 • tel 301.652.8827 • www.biomatsciences.com
510(k) Summary
- BioMat Sciences, Inc. 1. Submitter 5612 Glenwood Road Bethesda, MD 20817 Tel 301 652-3327 Fax 301 652-8827 Dr. Ivan Stangel (contact person) August 5, 1999 (date of preparation)
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- Device Name Trade name - Adhere Common name - Tooth bonding system Classification name - agent, tooth bonding, resin (per CFR 872.3200)
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- Legally marketed device for which substantial equivalence is being claimed
Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659)
4. Device Description
Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.
5. Intended Use of the Device
Adhere is used to bond restorative materials to enamel and dentin. The materials include composites, compomers, amalgam, ceramic veneers and ceramic inlays. In addition, Adhere is used to seal dentin, and reduce tooth sensitivity in non-bacterial mediated cervical lesions of teeth. Adhere is also used to promote composite bonds to ceramics and metals.
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- Technological Characteristics of Present Device Compared to Predicate Device Adhere is substantially equivalent to other legally marketed predicate dental devices. Substantial equivalence is based on performance and the use of components found in other legally marketed tooth bonding agents.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 1999
Mr. Ivan Stangel, D.M.D., F.A.D.M., F.I.C.D. President & Director of Research BioMat Sciences 5612 Glenwood Road Bethesda, MD 20817
K992838 Re : Adhere Conditioner, Adhere Primer, Adhere LC Trade Name: Adhesive, ADH Requlatory Class: II Product Code: KLE Dated: August 15, 1999 August 23, 1999 Received:
Dear Mr. Stangel:
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, qood 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Mr. Stangel
obligation you might have under sections 531 through 542 of obligation you magne 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 acberroom in possible equivalence of your device to a legally marketed predicate device results in a classification for your markees probles, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriance at (30 advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to
the regulation entification" (21 CFR 807.97). Other gener 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
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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7. Statement of Indications for Use:
- to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
- to seal dentinal tubules
- to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
- to promote bonds between incremental layers of composite resins when building a composite restoration
- to bond composite resins repairs to ceramics and metals
Prescription Usa Usa (Per 21 CFR 801.109)
Supam Runore