SCULPTURE PLUS NANO-HYBRID COMPOSITE— 510(k) K023742

Name: FDA 510(k) clearance K023742
Creator: U.S. Food and Drug Administration
Published: 2003-01-17

Substantially Equivalent

Pentron Laboratory Technologies

FDA 510(k) clearance K023742 for SCULPTURE PLUS NANO-HYBRID COMPOSITE, Substantially Equivalent on 2003-01-17. Applicant: Pentron Laboratory Technologies. Device class: 2.

Clearance details

Applicant: Pentron Laboratory Technologies
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2002-11-07
Decision date: 2003-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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