(43 days)
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
Concept HP Enamel is heat and pressure cured resin material to be used for the Concept in indirect inlay and onlay dental restorations.
The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene
Not Found
The provided document is a 510(k) Pre-market Notification letter from the FDA for a dental device (Concept HP Add-On and Concept HP Enamel). It confirms substantial equivalence to a predicate device for marketing purposes.
However, this document does not contain any information regarding:
- Acceptance criteria for device performance.
- The details of a study that proves the device meets specific acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.
Therefore, I cannot provide the requested information based on the given document. This FDA letter simply states that the device is substantially equivalent to existing devices and can be marketed, without detailing performance studies or their results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Ms. Donna M. Hartnett Director of Quality Assurance & Regulatory Affairs Ivovicar Vivadent, AG 175 Pineview Drive Amherst, New York 14228
Re: K033773
Trade/Device Name: Concept HP Add-On and Concept HP Enamel Regulation Number: 21 FR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 25, 2003 Received: December 12, 2003
Dear Ms. Hartnett:
This letter corrects our substantially equivalent letter of January 15, 2004 regarding the regulation name and number.
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 (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 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 - Ms. Hartnett
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clur L
Chiu Lin, Ph.D. 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): K033773
Device Name: Concept HP Add-On and Concept HP Enamel
Indications For Use:
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
Concept HP Enamel is heat and pressure cured resin material to be used for the Oonocpt in Eindirect inlay and onlay dental restorations.
The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Susa Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: K033773
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.