MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE— 510(k) K924824

Name: FDA 510(k) clearance K924824
Creator: U.S. Food and Drug Administration
Published: 1993-03-16

Substantially Equivalent

Unicep

FDA 510(k) clearance K924824 for MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE, Substantially Equivalent on 1993-03-16. Applicant: Unicep. Device class: 2.

Clearance details

Applicant: Unicep
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1992-09-28
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandpoint, ID, US

Download summary PDF View on FDA.gov ↗

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K925163 — MICODOSE CHLORHEXIPREP1993-05-27
K924821 — MICRODOSE PORCELAIN ETCHANT1993-03-16
K924823 — MICRODOSE SILANE1993-03-16
K925162 — MICRODOSE DENTIN CONDITIONER1993-03-16
K924822 — MICRODOSE ENAMEL ETCHANT1993-03-05

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