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FDA 510(k)

EXPASYL POWER APPLICATOR

K-Number: K051933 · 2006-01-03

ApplicantSybron Dental Specialties, Inc.
Decision Date2006-01-03
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXPASYL POWER APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 2006-01-03 under 510(k) number K051933. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPASYL POWER APPLICATOR?

EXPASYL POWER APPLICATOR is a medical device that received FDA 510(k) clearance on 2006-01-03. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K051933.

When did EXPASYL POWER APPLICATOR receive FDA 510(k) clearance?

EXPASYL POWER APPLICATOR received FDA 510(k) clearance on 2006-01-03, under 510(k) number K051933.

Who is the listed applicant for EXPASYL POWER APPLICATOR?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPASYL POWER APPLICATOR?

The FDA product code for EXPASYL POWER APPLICATOR is ELW.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: ELW)

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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