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510(k) K040857

MODIFICATION TO ADPER PROMPT by 3M Espe AG Dental Products — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2004
Date Received
April 2, 2004
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 3M Espe AG Dental Products

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  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K080514 — PECD-01 AND PECD QUICK-01 (March 26, 2008)
  • K072055 — LAVA FRAME, LAVA FRAME SHADE (February 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)

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  • 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)