(87 days)
Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.
Prime-Dent® Automix Dual Cure Core Build-Up Material
This is an FDA Premarket Notification (510(k)) K022675 for a dental material (Prime-Dent® Automix Dual Cure Core Build-Up Material), not a medical device that would typically undergo studies to demonstrate performance against computational acceptance criteria. The document is primarily concerned with establishing substantial equivalence to a predicate device based on material properties and intended use.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this type of submission.
The FDA's review for this device focused on its intended use as a "dental core build-up material either with adhesives or with pins or posts" and its classification as a "Tooth Shade Resin Material" under 21 CFR 872.3690. Substantial equivalence was determined based on comparisons to legally marketed predicate devices, not through a performance study against specific computational metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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City Health Service
00 Corporate Boulevaro Rockville MD 20850
7 2002 NOV
Mr. Rolando Marasigan V.P. of Manufacturing Prime Dental Manufacturing; Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618
Re: K022675
Trade/Device Name: Prime-Dent® Automix Dual Cure Core Build-Up Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 30, 2002 Received: November 11, 2002
Dear Mr. Marasigan:
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 vour 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.
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Page 2 - Mr. Rolando Marasigan
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 practicc 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 and additionally 21 CFR 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. 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,
Timothy A. Ulatowski 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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Page 1 of 1
510(k) Number (if known):
Device Name: Prime-Dent Automix Dual Cure Core Build Up Material
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and the comments of the
1022675
Indications For Use:
Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE: IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Susan Rusive
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number | 2002675 |
|---|---|
| --------------- | --------- |
§ 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.