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FDA 510(k)

Straumann® BLC Implants - Indication Widening

K-Number: K252168 · 2026-03-10

ApplicantInstitut Straumann AG
Decision Date2026-03-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann® BLC Implants - Indication Widening is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2026-03-10 under approval number K252168. 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® BLC Implants - Indication Widening?

Straumann® BLC Implants - Indication Widening is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Institut Straumann AG. The 510(k) number is K252168.

When was Straumann® BLC Implants - Indication Widening approved by the FDA?

Straumann® BLC Implants - Indication Widening received FDA 510(k) clearance on 2026-03-10, under approval number K252168.

What company makes Straumann® BLC Implants - Indication Widening?

Straumann® BLC Implants - Indication Widening is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann® BLC Implants - Indication Widening?

The FDA product code for Straumann® BLC Implants - Indication Widening 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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