SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER— 510(k) K973513

Name: FDA 510(k) clearance K973513
Creator: U.S. Food and Drug Administration
Published: 1997-12-22

Substantially Equivalent

Espe GmbH & Co. Kg.

FDA 510(k) clearance K973513 for SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER, Substantially Equivalent on 1997-12-22. Applicant: Espe GmbH & Co. Kg.. Device class: 2.

Clearance details

Applicant: Espe GmbH & Co. Kg.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1997-09-17
Decision date: 1997-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seefeld, DE

Download summary PDF View on FDA.gov ↗

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