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FDA 510(k)

STRAUMANN RC TEMPORARY ABUTMENTS

K-Number: K093027 · 2010-02-12

ApplicantStraumann USA
Decision Date2010-02-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN RC TEMPORARY ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K093027. 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 STRAUMANN RC TEMPORARY ABUTMENTS?

STRAUMANN RC TEMPORARY ABUTMENTS is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Straumann USA. The 510(k) number is K093027.

When did STRAUMANN RC TEMPORARY ABUTMENTS receive FDA 510(k) clearance?

STRAUMANN RC TEMPORARY ABUTMENTS received FDA 510(k) clearance on 2010-02-12, under 510(k) number K093027.

Who is the listed applicant for STRAUMANN RC TEMPORARY ABUTMENTS?

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 STRAUMANN RC TEMPORARY ABUTMENTS?

The FDA product code for STRAUMANN RC TEMPORARY ABUTMENTS 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 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.

View all 41 devices →

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

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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