ROOT CANAL XR— 510(k) K083062

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K083062 for ROOT CANAL XR, Substantially Equivalent on 2009-03-12. Applicant: S & C Polymer GmbH. Device class: 2.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2008-10-14
Decision date: 2009-03-12
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

K091735 — DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT2009-09-25
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K082115 — PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT2009-01-15
K081702 — CARBOXYLATE CEM, PHOSPHATE CEM2008-09-05
K042614 — S&C-SELF ETCH PR-BOND2004-11-22

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