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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 a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2022-01-28 under approval 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. It is manufactured by Institut Straumann AG. The 510(k) number is K212533.

When was BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants approved by the FDA?

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 approval number K212533.

What company makes 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 manufactured by Institut Straumann AG.

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.

Related Clinical Trials

NCT06086873 Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA RECRUITING

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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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