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510(k) K810498

CENTRIC (BITE) REGISTRATION PASTE by Wallace A. Erickson & Co. — Product Code EFH

K810498 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "CENTRIC (BITE) REGISTRATION PASTE". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Wallace A. Erickson & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
February 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paper, Articulation
Device Class
Class I
Regulation Number
872.6140
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)
  • 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)

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (February 10, 1997)
  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)
  • K864572 — FIXTECTOR (February 12, 1987)
  • K870032 — REVISED T-SCAN SYSTEM (February 2, 1987)
  • K832647 — ARTICULATING PAPER (February 21, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K771011 — ARTICULATING PAPER (June 20, 1977)
  • K770492 — CRACK DETECTOR, DEN-MAT (March 21, 1977)

FDA data resources