(84 days)
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No
The summary describes a dental adhesive and does not mention any AI or ML components or functionalities.
No
BeautiBond is a dental adhesive used for bonding filling material, and it does not directly treat a disease or condition in a therapeutic manner.
No
The device is a dental adhesive used for bonding dental filling material to teeth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "light-cured single-component dental adhesive," which is a physical material, not software.
Based on the provided information, BeautiBond is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to bond dental filling material to teeth (dentin or enamel) for restorations. This is a direct application within the body (or on a part of the body) for a therapeutic or restorative purpose.
- Device Description: It's described as a dental adhesive, which is a material used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to be used in vitro (outside the body) to analyze biological samples. BeautiBond is used in vivo (within the body) as part of a dental restoration procedure.
N/A
Intended Use / Indications for Use
BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.
Product codes
KLE, 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
Dentin or enamel for filling restorations of both anterior and posterior teeth.
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2008
Mr. David P. Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059
Re: K082744
Trade/Device Name: BeautiBond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE and EMA Dated: September 12, 2008 Received: September 18, 2008
Dear Mr. Morais:
We have reviewed your Section 510(k) premarket 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 - Mr. Morais
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); labeling (21 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) premarket notification. The FDA finding 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Suiste Y. Michan Oms.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1682744 510(k) Number (if known):
Device Name: BeautiBond
Indications For Use:
BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rinne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
İX
Shofu Dental Corporation BEAUTIBOND 510(k) Premarket Notification
510(k) Number: