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FDA 510(k)

HOLLOW BASKET TITANIUM DENTAL IMPLANT

K-Number: K801208 · 1980-05-28

ApplicantColmed, Ltd.
Decision Date1980-05-28
Product CodeELE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HOLLOW BASKET TITANIUM DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Colmed, Ltd.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801208. The device is classified under product code ELE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLOW BASKET TITANIUM DENTAL IMPLANT?

HOLLOW BASKET TITANIUM DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Colmed, Ltd.. The 510(k) number is K801208.

When did HOLLOW BASKET TITANIUM DENTAL IMPLANT receive FDA 510(k) clearance?

HOLLOW BASKET TITANIUM DENTAL IMPLANT received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801208.

Who is the listed applicant for HOLLOW BASKET TITANIUM DENTAL IMPLANT?

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

What is the FDA product code for HOLLOW BASKET TITANIUM DENTAL IMPLANT?

The FDA product code for HOLLOW BASKET TITANIUM DENTAL IMPLANT is ELE.

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Other records listing Colmed, Ltd. 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.

K811209JACOB WIRZ TRANSFIXATION PINK810636VARIODRAINK810117HALOGEN HEADLIGHT SYSTEMK801006CHARNLEY DESIGN HIP PROSTHESISK800762PS3 TITANIUM SCREW DENTAL IMPLANTK792241PELIMIT

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Related Devices (Code: ELE)

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Official Source

View on FDA Database →

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

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