OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT— 510(k) K891140

Name: FDA 510(k) clearance K891140
Creator: U.S. Food and Drug Administration
Published: 1989-05-01

Substantially Equivalent

Coe Laboratories, Inc.

FDA 510(k) clearance K891140 for OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT, Substantially Equivalent on 1989-05-01. Applicant: Coe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Coe Laboratories, Inc.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1989-03-03
Decision date: 1989-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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