ALPHA-DENT— 510(k) K940120

Substantially Equivalent

Wallace A. Erickson & Co.

FDA 510(k) clearance K940120 for ALPHA-DENT, Substantially Equivalent on 1994-02-25. Applicant: Wallace A. Erickson & Co.. Device class: 2.

Clearance details

Applicant: Wallace A. Erickson & Co.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1994-01-10
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Wallace A. Erickson & Co.

K984503 — ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-0001999-02-26
K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLER1996-12-06
K960667 — CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE1996-07-02
K960365 — ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)1996-03-28
K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT1996-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.