Cleared Traditional

K760755 - CUTTER SIL-SILICONE IMPRESSION MAT

K760755 is an FDA 510(k) clearance for CUTTER SIL-SILICONE IMPRESSION MAT, manufactured by Cutter Laboratories, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K760755 · Cutter Laboratories, Inc. · Dental device
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Oct 1976
Decision
14d
Days
Class 2
Risk

K760755 is an FDA 510(k) clearance for the CUTTER SIL-SILICONE IMPRESSION MAT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1976 after a review of 14 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 Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K760755

510(k) Number K760755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1976
Decision Date October 15, 1976
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
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 326
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K760755.
PERMAGUM
K771627 · Espe GmbH (Us) · Sep 1977
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753 · Cutter Laboratories, Inc. · Oct 1976
CUTTER FLEX-SILICONE IMPRESSION MAT.
K760752 · 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