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FDA 510(k)

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

K-Number: K052741 · 2006-01-13

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2006-01-13
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K052741. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES?

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K052741.

When did IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES receive FDA 510(k) clearance?

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES received FDA 510(k) clearance on 2006-01-13, under 510(k) number K052741.

Who is the listed applicant for IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES?

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

What is the FDA product code for IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES?

The FDA product code for IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES is EBW.

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Related Devices (Code: EBW)

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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