Cleared Traditional

K810825 - POLYVINYL SILICONE IMPRESSION MATERIAL

K810825 is an FDA 510(k) clearance for POLYVINYL SILICONE IMPRESSION MATERIAL, manufactured by Dental-Material Gesellschaft. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K810825 · Dental-Material Gesellschaft · Dental device
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Apr 1981
Decision
21d
Days
Class 2
Risk

K810825 is an FDA 510(k) clearance for the POLYVINYL SILICONE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dental-Material Gesellschaft (Walker, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 21 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 Dental-Material Gesellschaft devices

FDA 510(k) Submission Details - K810825

510(k) Number K810825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 14, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 128d · This submission: 21d
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 K810825.
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679 · G-C Intl. Corp. · Oct 1981
SR-ALGICAP
K811867 · J. Aderer, Inc. · Oct 1981
SR-IVOSEAL
K810523 · J. Aderer, Inc. · Apr 1981
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
CROWN DELTA SILICONE IMPRESSION MATERIAL
K801380 · Crown Delta Corp. · Jul 1980