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FDA 510(k)

OSSEODENT PROSTHETIC KIT

K-Number: K895333 · 1989-11-29

ApplicantCeltrix Laboratories
Decision Date1989-11-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEODENT PROSTHETIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Celtrix Laboratories. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K895333. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEODENT PROSTHETIC KIT?

OSSEODENT PROSTHETIC KIT is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Celtrix Laboratories. The 510(k) number is K895333.

When did OSSEODENT PROSTHETIC KIT receive FDA 510(k) clearance?

OSSEODENT PROSTHETIC KIT received FDA 510(k) clearance on 1989-11-29, under 510(k) number K895333.

Who is the listed applicant for OSSEODENT PROSTHETIC KIT?

The FDA 510(k) record lists Celtrix Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSEODENT PROSTHETIC KIT?

The FDA product code for OSSEODENT PROSTHETIC KIT is DZE.

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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