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FDA 510(k)

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS

K-Number: K130808 · 2013-06-28

ApplicantStraumann USA
Decision Date2013-06-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2013-06-28 under 510(k) number K130808. 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 STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS?

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Straumann USA. The 510(k) number is K130808.

When did STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS receive FDA 510(k) clearance?

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS received FDA 510(k) clearance on 2013-06-28, under 510(k) number K130808.

Who is the listed applicant for STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS?

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 HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS?

The FDA product code for STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS is NHA.

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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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