POLYDIMETHYLSILOXANE IMPRESSION MATERIAL— 510(k) K131510

Name: FDA 510(k) clearance K131510
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Blackwell Device Consulting

FDA 510(k) clearance K131510 for POLYDIMETHYLSILOXANE IMPRESSION MATERIAL, Substantially Equivalent on 2013-12-20. Applicant: Blackwell Device Consulting. Device class: 2.

Clearance details

Applicant: Blackwell Device Consulting
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2013-05-24
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Catawba, NC, US

Download summary PDF View on FDA.gov ↗

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