IMPRESSION MATERIAL, TRIFLEX SILICONE— 510(k) K760238

Name: FDA 510(k) clearance K760238
Creator: U.S. Food and Drug Administration
Published: 1976-07-26

Substantially Equivalent

Oratec Dental Products

FDA 510(k) clearance K760238 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: Product 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 ↗

Recent devices under product code ELW

view all

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Oratec Dental Products

view all

K760239 — CEMENT, ULTRA-BOND1976-07-26
K760240 — IMPRESSION MATERIAL, TRIFLEX SILICONE1976-07-26

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