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510(k) K960165

ALPHA-DENT COMPOSITE SURFACE SEALANT by Wallace A. Erickson & Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • K960365 — ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) (March 28, 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)

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