(73 days)
Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, the results of a study, or any details related to device performance in the context of a clinical or analytical study. The document is an FDA 510(k) clearance letter for a dental device named "Yellow Special," indicating that it has been found substantially equivalent to a predicate device. It lists the device name, regulation number, product code, and indications for use, but no performance data, study design, or acceptance criteria are discussed.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 3 2002
Mr. Bruce Barton Official Correspondent Metalor Technologies USA Dental Division 255 John L. Dietsch Boulevard North Attleborough, Massachusetts 02761
Re: K013506
Trade/Device Name: Yellow Special Regulation Number: 872.3060 Regulation Name: Metalor Yellow Special Regulatory Class: II Product Code: EJT Dated: October 17, 2001 Received: October 22, 2001
Dear Mr. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed young young 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antendinents, or to arrises and Cosmetic Act (Act) that do not require approval of a premarket the rederal F 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the samual 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 (1 wr ), it has of 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
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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 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,
Patricia Cuscate for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K013506 |
|---|---|
| Device Name: | Yellow Special |
Indications For Use:
Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
ি10(k) Number ___________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96) page 12
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.