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Bluephase Style

by Ivoclar Vivadent, Inc.

510(k) K110756

Bluephase Style is a Class II device made by Ivoclar Vivadent, Inc., cleared under FDA 510(k) K110756 on 29 Aug 2011, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110756 Date29 Aug 2011ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1740-2014 FDA Class II initiated 14 Apr 2014

    A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

Timeline

2 dated events

  1. Cleared FDA 510(k) K110756
  2. Recall initiated FDA recalls Z-1740-2014

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  • Withdrawn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
EBZ
Device class
Class II
Regulation
21 CFR Part 872.6070
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).

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