Cleared Traditional

K760238 - IMPRESSION MATERIAL, TRIFLEX SILICONE

K760238 is an FDA 510(k) clearance for IMPRESSION MATERIAL, manufactured by Oratec Dental Products. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K760238 · Oratec Dental Products · Dental device
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Jul 1976
Decision
11d
Days
Class 2
Risk

K760238 is an FDA 510(k) clearance for the IMPRESSION MATERIAL, TRIFLEX SILICONE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Oratec Dental Products (Mchenry, US). The FDA issued a Cleared decision on July 26, 1976 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oratec Dental Products devices

FDA 510(k) Submission Details - K760238

510(k) Number K760238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1976
Decision Date July 26, 1976
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 128d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 334
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K760238.
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753 · Cutter Laboratories, Inc. · Oct 1976
CUTTER FLEX-SILICONE IMPRESSION MAT.
K760752 · Cutter Laboratories, Inc. · Oct 1976
CUTTER SIL-SILICONE IMPRESSION MAT
K760755 · Cutter Laboratories, Inc. · Oct 1976
PUTTY, ACCOE
K760225 · Coe Laboratories, Inc. · Jul 1976
PASTE, ACCOE IMPRESSION
K760226 · Coe Laboratories, Inc. · Jul 1976
IMPRESSION MATERIAL, DENTAL SILICON RTV
K760231 · Crown Delta Corp. · Jul 1976