Cleared Traditional

K780778 - RTV SILICONE HAND KNEADABLE PUTTY

K780778 is an FDA 510(k) clearance for RTV SILICONE HAND KNEADABLE PUTTY, manufactured by Crown Delta Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K780778 · Crown Delta Corp. · Dental device
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May 1978
Decision
20d
Days
Class 2
Risk

K780778 is an FDA 510(k) clearance for the RTV SILICONE HAND KNEADABLE PUTTY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Crown Delta Corp. (Walker, US). The FDA issued a Cleared decision on May 31, 1978 after a review of 20 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 Crown Delta Corp. devices

FDA 510(k) Submission Details - K780778

510(k) Number K780778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1978
Decision Date May 31, 1978
Days to Decision 20 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
107d faster than avg
Panel avg: 127d · This submission: 20d
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 265
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K780778.
REFLECT IMPRESSION MATERIAL
K781689 · Kerr Corporation (Danbury) · Nov 1978
DENTAL SILICONE IMPRESSION MATERIAL
K781083 · Crown Delta Corp. · Aug 1978
REPROSIL
K781151 · Dentsply Intl. · Aug 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