(52 days)
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Not Found
No
The 510(k) summary describes a dental adhesive and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is a dental adhesive used for bonding and repairing, which are restorative rather than therapeutic functions.
No
Explanation: The device is a dental adhesive used for bonding restorations and sealing sensitive teeth. Its function is to facilitate treatment by bonding materials, not to diagnose a condition or disease.
No
The device is a dental adhesive, which is a physical material, not software. The description clearly indicates its use in bonding dental restorations and fillings.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of "One Coat SE Bond" is for bonding dental restorations directly to tooth structure. This is a direct application to the patient's body, not an examination of a specimen taken from the body.
- The intended uses are all related to dental procedures. Bonding fillings, repairing restorations, and sealing sensitive teeth are all clinical dental treatments.
- There is no mention of analyzing biological samples. The description focuses on the adhesive properties and applications within the mouth.
Therefore, "One Coat SE Bond" is a dental adhesive used in clinical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
One Coat SE Bond, a self etching dental adhesive, is indicated for the following:
- The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
- The bonding of direct fillings of composite or compomer. .
- The bonding of composite to amalgam. .
- The repairing of metal/ceramic, ceramic or composite restorations. .
- The sealing of sensitive teeth. .
Product codes
KLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tooth structure
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2004
Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128
Re: K033760
Trade/Device Name: One Coat SE Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: November 28, 2003 Received: December 02, 2003
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revewed your Section 770(x) premained is substantially equivalent (for the indications for referenced above and have decemined are ed predicate devices marketed in interstate since show use stated in the encreating thanksettle Medical Device Amendments, or to devices that prior to May 26, 1970, the chacinent and of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with are proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, sabject to the general registration, listing of devices, good controls provisions of the fiel measure prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) microsoft regulations affecting your device can be
may be subject to such additional controls. Existing major regulations of DA may may be subject to such additional controls. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -- Mr. Henry J. Vogelstein
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); an the rece of 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) This lotter will and my Jowe FDA finding of substantial equivalence of your device to a legally premated notificated evice 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 If you desire specific at not is 101 ) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, and wate 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chas.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K033760
Device Name: One Coat SE Bond
Indications for Use:
One Coat SE Bond, a self etching dental adhesive, is indicated for the following:
- The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
- The bonding of direct fillings of composite or compomer. .
- The bonding of composite to amalgam. .
- The repairing of metal/ceramic, ceramic or composite restorations. .
- The sealing of sensitive teeth. .
Prescription Use
(21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K033760
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