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510(k) K183424

Ambar, Ambar APS, Ambar Universal APS by Dentscare Ltda — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
December 11, 2018
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

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