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510(k) K210186

PacBond One by Pac-Dent, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
January 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Pac-Dent, Inc.

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  • K210189 — Pac-Dent Denture Base Resin (July 28, 2021)
  • K210412 — Pac-Dent Ceramic Nanohybrid Resin (July 26, 2021)
  • K201182 — iMask Disposable Surgical Face Mask (February 19, 2021)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)

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  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)