RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT— 510(k) K894315

Name: FDA 510(k) clearance K894315
Creator: U.S. Food and Drug Administration
Published: 1989-10-31

Substantially Equivalent

Lee Pharmaceuticals

FDA 510(k) clearance K894315 for RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT, Substantially Equivalent on 1989-10-31. Applicant: Lee Pharmaceuticals. Device class: 2.

Clearance details

Applicant: Lee Pharmaceuticals
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1989-07-14
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South El Monte, CA, US

Download summary PDF View on FDA.gov ↗

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