PREMIER CERAMIC PRIMER— 510(k) K131212

Name: FDA 510(k) clearance K131212
Creator: U.S. Food and Drug Administration
Published: 2013-08-26

Substantially Equivalent

Premier Dental Products Co.

FDA 510(k) clearance K131212 for PREMIER CERAMIC PRIMER, Substantially Equivalent on 2013-08-26. Applicant: Premier Dental Products Co.. Device class: 2.

Clearance details

Applicant: Premier Dental Products Co.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2013-04-29
Decision date: 2013-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth Meeting, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K251587 — VITA VMLC Primer2026-02-23

More clearances from Premier Dental Products Co.

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K141839 — PREMIER ETCH2014-11-17
K132526 — KNIT-PAK+2013-11-26
K083695 — TRAXODENT2009-04-28
K062166 — ENAMEL PRO2006-11-21
K062683 — ENAMEL PRO VARNISH2006-11-21

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