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FDA 510(k)

Angled Screwdriver MED (M-SD090)

K-Number: K253655 · 2026-07-31

ApplicantW&H Dentalwerk Bürmoos GmbH
Decision Date2026-07-31
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Angled Screwdriver MED (M-SD090) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Bürmoos GmbH. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K253655. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Angled Screwdriver MED (M-SD090)?

Angled Screwdriver MED (M-SD090) is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is W&H Dentalwerk Bürmoos GmbH. The 510(k) number is K253655.

When did Angled Screwdriver MED (M-SD090) receive FDA 510(k) clearance?

Angled Screwdriver MED (M-SD090) received FDA 510(k) clearance on 2026-07-31, under 510(k) number K253655.

Who is the listed applicant for Angled Screwdriver MED (M-SD090)?

The FDA 510(k) record lists W&H Dentalwerk Bürmoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Angled Screwdriver MED (M-SD090)?

The FDA product code for Angled Screwdriver MED (M-SD090) is DZI.

Other records listing W&H Dentalwerk Bürmoos GmbH as applicant

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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Related Devices (Code: DZI)

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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