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510(k) K200462

EtchPro Etching Gel by Belport Company, Inc., Gingi-Pak — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2020
Date Received
February 25, 2020
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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Other clearances for product code KLE

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  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, (November 1, 2024)
  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)