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510(k) K802681

HELIOBOND by Vivadent (Usa), Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1980
Date Received
October 28, 1980
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 Vivadent (Usa), Inc.

  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K823409 — HELIOSIT-ORTHODONTIC (January 21, 1983)
  • K813015 — HELIOSEAL (December 2, 1981)
  • K802679 — SILANIT (December 17, 1980)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802682 — CONTACT SEAL (November 24, 1980)
  • K802683 — HELIOSIT (November 24, 1980)
  • K802680 — ISOPAST-DS (November 12, 1980)
  • K802685 — REOLIT (November 12, 1980)
  • K801227 — SILICAP (August 12, 1980)

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  • 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)