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510(k) K202920

OptiComp by Pac-Dent, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2022
Date Received
September 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Pac-Dent, Inc.

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  • K210412 — Pac-Dent Ceramic Nanohybrid Resin (July 26, 2021)
  • K210186 — PacBond One (July 16, 2021)
  • K201182 — iMask Disposable Surgical Face Mask (February 19, 2021)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)

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