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FDA 510(k)

W&H HANDPIECE ANESTO, MODEL: RA-5

K-Number: K083811 · 2010-01-14

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2010-01-14
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

W&H HANDPIECE ANESTO, MODEL: RA-5 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 2010-01-14 under 510(k) number K083811. The device is classified under product code EGM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the W&H HANDPIECE ANESTO, MODEL: RA-5?

W&H HANDPIECE ANESTO, MODEL: RA-5 is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K083811.

When did W&H HANDPIECE ANESTO, MODEL: RA-5 receive FDA 510(k) clearance?

W&H HANDPIECE ANESTO, MODEL: RA-5 received FDA 510(k) clearance on 2010-01-14, under 510(k) number K083811.

Who is the listed applicant for W&H HANDPIECE ANESTO, MODEL: RA-5?

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 W&H HANDPIECE ANESTO, MODEL: RA-5?

The FDA product code for W&H HANDPIECE ANESTO, MODEL: RA-5 is EGM.

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Related Devices (Code: EGM)

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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