CERAM-PRIME— 510(k) K002502

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K002502 for CERAM-PRIME, Substantially Equivalent on 2000-11-08. Applicant: S & C Polymer GmbH. Device class: 2.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2000-08-14
Decision date: 2000-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

Download summary PDF View on FDA.gov ↗

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More clearances from S & C Polymer GmbH

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K083766 — PHOGLASS CEM2009-03-02
K082115 — PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT2009-01-15
K081702 — CARBOXYLATE CEM, PHOSPHATE CEM2008-09-05

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