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Revolution Formula 2

by Sybron Dental Specialties, Inc.

510(k) K013647

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013647 Date16 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0716-2011 FDA Unclassified (pre-2012) initiated 15 Oct 2010

    Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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    Class II

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    Class II

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