(141 days)
Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental cement called "Hy-Bond Resiglass." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the document:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document does not list any specific acceptance criteria or performance metrics for the device. The FDA's determination is based on substantial equivalence to predicate devices, not on the demonstration of meeting specific performance criteria detailed here.
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Sample size used for the test set and the data provenance:
- Cannot be provided. The document does not describe any test sets or studies performed by the manufacturer to establish performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The document does not describe any test sets or expert involvement in establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. The document does not describe any test sets or adjudication methods.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, nor is this an AI device. This device is a dental cement, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a dental cement, not an algorithm, so the concept of standalone performance does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document does not describe any ground truth establishment for performance testing. Substantial equivalence for this type of device typically relies on demonstrating similar physical and chemical properties and intended use to existing marketed devices.
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The sample size for the training set:
- Cannot be provided. The document does not describe any training sets.
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How the ground truth for the training set was established:
- Cannot be provided. The document does not describe any training sets or ground truth establishment for them.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David P. Morais Operations Manager and Official Correspondent SHOFU DENTAL CORPORATION 1225 Stone Drive San Marcos, California 92078
FEB -3 2012
Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 19, 2011 Received: October 20, 2011
Trade/Device Name: Hy-Bond Resiglass
Dear Mr. Morais:
Re: K111855
This letter corrects our substantially equivalent letter of November 17, 2011.
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.
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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 Office of Compliance at (301) 594-4618. 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). 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,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number (if known):
· Device Name: Hy-Bond Resiglass
Indications For Use:
Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.
Prescription Use × (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K111855 |
|---|---|
| ---------------- | --------- |
Shofu Dental Corporation
HY-BOND RESIGLASS 510(k) Premarket Notification
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.