ALPHA-DENT ROOT CANAL SEALER & FILLER— 510(k) K963922

Name: FDA 510(k) clearance K963922
Creator: U.S. Food and Drug Administration
Published: 1996-12-06

Substantially Equivalent

Wallace A. Erickson & Co.

FDA 510(k) clearance K963922 for ALPHA-DENT ROOT CANAL SEALER & FILLER, Substantially Equivalent on 1996-12-06. Applicant: Wallace A. Erickson & Co.. Device class: 2.

Clearance details

Applicant: Wallace A. Erickson & Co.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1996-09-30
Decision date: 1996-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Wallace A. Erickson & Co.

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K984503 — ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-0001999-02-26
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
K960122 — ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL1996-02-21

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