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FDA 510(k)

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

K-Number: K212533 · 2022-01-28

ApplicantInstitut Straumann AG
Decision Date2022-01-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants 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 2022-01-28 under 510(k) number K212533. 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 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants?

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Institut Straumann AG. The 510(k) number is K212533.

When did BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants receive FDA 510(k) clearance?

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants received FDA 510(k) clearance on 2022-01-28, under 510(k) number K212533.

Who is the listed applicant for BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants?

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 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants?

The FDA product code for BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants is DZE.

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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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