(182 days)
- Direct restorations with light-cured composite resin
- Repairs of fractured restorations with light-cured composite resin
- Cementation of indirect restorations with light- or dual-cured resin cement
- Core build-up with light- or dual-cured core materials
Not Found
The provided text is related to an FDA 510(k) clearance for a dental bonding agent called "BeautiBond Universal". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- Trade/Device Name: BeautiBond Universal
- Regulation Number: 21 CFR 872.3200
- Regulation Name: Resin Tooth Bonding Agent
- Regulatory Class: Class II
The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of study detailed in the request. For a Class II device like this bonding agent, substantial equivalence is typically established by comparing the device's technological characteristics and performance data to that of a predicate device. This usually involves bench testing (e.g., bond strength, cytotoxicity, biocompatibility) rather than studies with expert readers, AI, or ground truth as described in the prompt.
Therefore, I cannot provide the requested information based on the given text. The text does not detail:
- Acceptance criteria table or reported device performance against such criteria.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study or effect sizes of human readers with/without AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
This is a regulatory clearance document for a physical medical device, not a software or AI-powered device, hence the absence of such information.
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September 26, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
Shofu Dental Corporation Mauro Malzyner Regulatory Affairs Coordinator 1225 Stone Drive San Marcos, California 92078
Re: K180803
Trade/Device Name: BeautiBond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EMA, EBF Dated: July 2, 2018 Received: July 5, 2018
Dear Mauro Malzyner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S3
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
BeautiBond Universal
Indications for Use (Describe)
- · Direct restorations with light-cured composite resin
- · Repairs of fractured restorations with light-cured composite resin
- · Cementation of indirect restorations with light- or dual-cured resin cement
- · Core build-up with light- or dual-cured core materials
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.