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FDA 510(k)

PYROLITE CARBON ENDOSSEOUS DENTAL IMPL

K-Number: K791237 · 1979-08-28

Decision Date1979-08-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PYROLITE CARBON ENDOSSEOUS DENTAL IMPL is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K791237. 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 PYROLITE CARBON ENDOSSEOUS DENTAL IMPL?

PYROLITE CARBON ENDOSSEOUS DENTAL IMPL is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Carbomedics, Inc.. The 510(k) number is K791237.

When did PYROLITE CARBON ENDOSSEOUS DENTAL IMPL receive FDA 510(k) clearance?

PYROLITE CARBON ENDOSSEOUS DENTAL IMPL received FDA 510(k) clearance on 1979-08-28, under 510(k) number K791237.

Who is the listed applicant for PYROLITE CARBON ENDOSSEOUS DENTAL IMPL?

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

What is the FDA product code for PYROLITE CARBON ENDOSSEOUS DENTAL IMPL?

The FDA product code for PYROLITE CARBON ENDOSSEOUS DENTAL IMPL is DZE.

Related Clinical Trials

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.

Other records listing Carbomedics, Inc. as applicant

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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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.

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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