VERA PDN

K972118 · Aalba Dent, Inc. · EJH · Aug 15, 1997 · Dental

Device Facts

• Record ID: K972118
• Device Name: VERA PDN
• Applicant: Aalba Dent, Inc.
• Product Code: EJH · Dental
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2

Intended Use

VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for the fabrication of custom-made removable denture appliances.

Device Story

VERA PDN is a cobalt-chromium based alloy supplied in nugget form. It is intended for use by dental laboratory technicians to fabricate custom-made removable denture appliances. The alloy is melted and cast to form the structural framework of dental prosthetics. The device provides a durable, biocompatible material for dental restoration, enabling the creation of removable appliances that restore patient oral function and aesthetics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cobalt-chromium based alloy; supplied in nugget form for dental casting; intended for fabrication of removable denture frameworks.

Indications for Use

Indicated for the fabrication of custom-made removable denture appliances.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aalba Dent, Incorporated C/O Robert W. Bauer, Ph.D. 1819 South May Street, 2F Chicago, Illinois 60608 --

AUG 1 5 1997

K972118 Re : Trade Name: Vera PDN Requlatory Class: II Product Code: EJH Dated: June 2, 1997 Received: June 5, 1997

Dear Dr. Bauer:

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 aqainst 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. A 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 requlation (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 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

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Page 2 - Dr. Bauer

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 qeneral 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
K. Clatrust.

Timoth x A. Ul 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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Page / of /

977118 510(k) Number (if known): K

VERA PDN Device Name:

Indications For Use:

VERA PDN, a cobalt-chromium based alloy in nugget form, is VERA PDN, a cobart-chiomical based arroy 2007 by and of custom-made removable denture appliances.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Rumpes

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972118

Prescription Use V (Per 21 CFR 801.109)

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Over-The-Counter Use___________

(Optional Format 1-2-96)

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