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FDA 510(k)

CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS

K-Number: K080286 · 2008-03-07

ApplicantStraumann USA
Decision Date2008-03-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2008-03-07 under 510(k) number K080286. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS?

CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Straumann USA. The 510(k) number is K080286.

When did CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS receive FDA 510(k) clearance?

CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS received FDA 510(k) clearance on 2008-03-07, under 510(k) number K080286.

Who is the listed applicant for CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS?

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

What is the FDA product code for CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS?

The FDA product code for CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS is NHA.

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 Straumann USA 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: NHA)

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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