Home / 510(k) Clearances / K960365

510(k) K960365

ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) by Wallace A. Erickson & Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
January 25, 1996
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 Wallace A. Erickson & Co.

  • K984503 — ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 (February 26, 1999)
  • K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLER (December 6, 1996)
  • K960667 — CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE (July 2, 1996)
  • K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT (March 15, 1996)
  • K960122 — ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL (February 21, 1996)
  • K955521 — ALPHA-DENT COPAL CAVITY VARNISH (January 24, 1996)
  • K955089 — ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT (December 13, 1995)
  • K942742 — ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV (August 29, 1994)
  • K942727 — ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE (August 23, 1994)
  • K935625 — ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE (August 10, 1994)

Other clearances for product code KLE

  • K252450 — Adhese 2 (March 5, 2026)
  • 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)