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510(k) K934248

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER by Wallace A. Erickson & Co. — Product Code EBI

K934248 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER". The FDA issued a decision of Substantially Equivalent on December 8, 1993. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Wallace A. Erickson & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1993
Date Received
August 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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 EBI

  • K262300 — Denture Base Resin V2 (July 8, 2026)
  • K261474 — DENTCA Tru Flexible (July 1, 2026)
  • K260569 — DB 4000 High Impact Denture Base (June 2, 2026)
  • K260376 — Denture Base (May 6, 2026)
  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)

FDA data resources