(37 days)
This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
nonprecious, nickel-chromium-molybdenum based ceramic casting alloy
The provided document is an FDA 510(k) clearance letter for a dental alloy named "VeraBond 2." This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance letter rather than a technical study report.
Therefore, I cannot provide the requested information from this document. The letter simply states that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed. It refers to the "indications for use" as stated in an enclosure, but the enclosure itself (which would detail the device's properties and intended use) is not present in the provided text.
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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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 1998
Mr. Vincent M. Benetti General Manager Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94585
Re : K982094 Trade Name: VeraBond 2 Regulatory Class: II Product Code: EJH Dated: June 10, 1998 June 15, 1998 Received:
Dear Mr. Benetti:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Benetti
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation 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" (21 CFR 807.97). Other general information on your responsibilities under the Accident obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Sutman 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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of_1 Page_
510 (k) Number (if known)
Device Name:_ VeraBond 2
Indications For Use:
This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use_
(Optional Format 1-2-96)
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.