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FDA 510(k)

REVOLUTION FORMULA 2

K-Number: K013647 · 2002-01-16

ApplicantSybron Dental Specialties, Inc.
Decision Date2002-01-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVOLUTION FORMULA 2 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 2002-01-16 under 510(k) number K013647. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVOLUTION FORMULA 2?

REVOLUTION FORMULA 2 is a medical device that received FDA 510(k) clearance on 2002-01-16. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K013647.

When did REVOLUTION FORMULA 2 receive FDA 510(k) clearance?

REVOLUTION FORMULA 2 received FDA 510(k) clearance on 2002-01-16, under 510(k) number K013647.

Who is the listed applicant for REVOLUTION FORMULA 2?

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 REVOLUTION FORMULA 2?

The FDA product code for REVOLUTION FORMULA 2 is EBF.

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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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