Cleared Traditional

K780164 - RTV DENTAL SILICONE

K780164 is an FDA 510(k) clearance for RTV DENTAL SILICONE, manufactured by Tydont, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K780164 · Tydont, Inc. · Dental device
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Mar 1978
Decision
43d
Days
Class 2
Risk

K780164 is an FDA 510(k) clearance for the RTV DENTAL SILICONE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Tydont, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978 after a review of 43 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 Tydont, Inc. devices

FDA 510(k) Submission Details - K780164

510(k) Number K780164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1978
Decision Date March 15, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 128d · This submission: 43d
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 K780164.
DENTAL SILICONE IMPRESSION MATERIAL
K781083 · Crown Delta Corp. · Aug 1978
REPROSIL
K781151 · Dentsply Intl. · Aug 1978
RTV SILICONE HAND KNEADABLE PUTTY
K780778 · Crown Delta Corp. · May 1978
PERMAGUM ADHESIVE
K771853 · Espe GmbH (Us) · Oct 1977
PERMAGUM
K771627 · Espe GmbH (Us) · Sep 1977
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753 · Cutter Laboratories, Inc. · Oct 1976