VERA PD SOLDER

K972632 · Aalba Dent, Inc. · EJT · Aug 15, 1997 · Dental

Device Facts

• Record ID: K972632
• Device Name: VERA PD SOLDER
• Applicant: Aalba Dent, Inc.
• Product Code: EJT · Dental
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge restorations.

Device Story

Vera PD Solder is a white-colored dental alloy used by dental professionals for the construction and repair of crown and bridge restorations. It functions as a soldering or welding material to join or repair dental prosthetic components. The device is intended for prescription use in a clinical or laboratory setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

White-colored dental soldering/welding alloy. Class II dental device per 21 CFR 872.3060.

Indications for Use

Indicated for use in the construction and repair of crown and bridge restorations in dental patients.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the central symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vincent Benetti General Manager Aalba Dent, Incorporated . ........... 400 Watt Drive Cordelia, California 94585

Aug 1 5 1997

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K972632 Re : Vera PD Solder Trade Name: Regulatory Class: II Product Code: EJT Dated: July 2, 1997 Received: July 14, 1997

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 able beated in the 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Benetti

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fida.gov/cdrh/dsmamain.html".

Sincerely yours

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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X972632_ 510(k) Number (if known): _

Vera PD Solder__ Device Name:_

Indications For Use:

This device is a "white" colored, soldering (welding) This device is a "white" construction and repair of crown and alloy for use in the constitucion and reported. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification
to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the class II to 21 CFR Ch.I (4-1-69 Ed.) Part 0757 and device.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )

Concurrence of CDRH, OFFIce of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, In and General Hos 5 1 O(k) Number

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The Counter Use_

(Optional Format 1-2-96)