510(k) K082974

MYSTIQUE MB CERAMIC BRACKETS by Dentsply Interntional — Product Code NJM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 7, 2008
Date Received: October 6, 2008
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bracket, Ceramic, Orthodontic
Device Class: Class II
Regulation Number: 872.5470
Review Panel: DE
Submission Type

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

Other clearances by Dentsply Interntional

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K090454 — ALLURE MB CERAMIC BRACKETS (March 20, 2009)
K082973 — STER-MATE STERILE LAVAGE KIT (January 29, 2009)
K081291 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION (May 22, 2008)
K080311 — MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM (April 18, 2008)
K080246 — COMPOSITE ALIGNER BUTTON (April 11, 2008)
K080203 — MTA ROOT CANAL SEALER (March 26, 2008)
K073173 — SELF-ADHESIVE RESIN CEMENT (January 23, 2008)
K073218 — MTA ADVANCED MATERIAL (January 7, 2008)

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