(17 days)
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Not Found
No
The document describes a light-cure resin adhesive for bonding orthodontic brackets and dental restorations. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is an adhesive used to bond orthodontic brackets and dental restorations, which is a structural or supportive function, not a direct therapeutic treatment for a disease or condition.
No
Explanation: The device is an orthodontic adhesive used to bond dental elements, not to diagnose a condition.
No
The device description is not found, but the intended use clearly describes a physical orthodontic adhesive, which is a material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to bond materials to teeth, which are part of the human body, but it does not involve the examination of bodily specimens like blood, urine, tissue, etc.
- The intended use describes a bonding process for dental procedures. This is a therapeutic or restorative application, not a diagnostic one.
The description clearly outlines a dental adhesive used for bonding orthodontic brackets, bands, and non-opaque dental restorations directly to teeth. This falls under the category of dental devices used for treatment and restoration, not for diagnosing conditions by examining bodily samples.
N/A
Intended Use / Indications for Use
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).
The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.
Product codes
DYII, EMA
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 or teeth
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K040548
Trade/Devicc Name: Aegis® ORTHO Light-Cured Orthodontic Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYII and EMA Dated: February 27, 2004 Received: March 09, 2004
Dear Ms. Goldstein:
We have reviewed your Scction 510(k) promarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Mildred M. Goldstein
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. or the receir any a with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and incine ts 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) premarket notification. The FDA finding of substantial equivalence of your device to a promance tected 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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" (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,
Cl
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
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Page 1 of 1
510(K) Number: K0406548
Device Name: Aegis-ORTHO Light-Cured Orthodontic Adhesive
INDICATIONS FOR USE:
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).
The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1/2/96)
Sura Ruore
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040548