IMPRESSION MATERIAL, TRIFLEX SILICONE— 510(k) K760240

Name: FDA 510(k) clearance K760240
Creator: U.S. Food and Drug Administration
Published: 1976-07-26

Substantially Equivalent

Oratec Dental Products

FDA 510(k) clearance K760240 for IMPRESSION MATERIAL, TRIFLEX SILICONE, Substantially Equivalent on 1976-07-26. Applicant: Oratec Dental Products. Device class: 2.

Clearance details

Applicant: Oratec Dental Products
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1976-07-15
Decision date: 1976-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K760238 — IMPRESSION MATERIAL, TRIFLEX SILICONE1976-07-26
K760239 — CEMENT, ULTRA-BOND1976-07-26

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