IMPREFLEX ALGINATE IMPRESSION MATERIAL— 510(k) K771120

Substantially Equivalent

Espe Dental Products

FDA 510(k) clearance K771120 for IMPREFLEX ALGINATE IMPRESSION MATERIAL, Substantially Equivalent on 1977-08-03. Applicant: Espe Dental Products. Device class: 2.

Clearance details

Applicant
Espe Dental Products
Product code
Code LEW
Device class
Class 2
Regulation
21 CFR 862.3880
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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