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FDA 510(k)

TLX SRAs and TLX Gold Abutments

K-Number: K213063 · 2022-04-08

ApplicantInstitut Straumann AG
Decision Date2022-04-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TLX SRAs and TLX Gold Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K213063. 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 TLX SRAs and TLX Gold Abutments?

TLX SRAs and TLX Gold Abutments is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Institut Straumann AG. The 510(k) number is K213063.

When did TLX SRAs and TLX Gold Abutments receive FDA 510(k) clearance?

TLX SRAs and TLX Gold Abutments received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213063.

Who is the listed applicant for TLX SRAs and TLX Gold Abutments?

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

What is the FDA product code for TLX SRAs and TLX Gold Abutments?

The FDA product code for TLX SRAs and TLX Gold Abutments is NHA.

Other records listing Institut Straumann AG as applicant

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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.

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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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