Cleared Traditional

K951075 - S & C VINYL POLYSILOXANE IMPRESSION MATERIAL

K951075 is an FDA 510(k) clearance for S & C VINYL POLYSILOXANE IMPRESSION MAT..., manufactured by S & C Polymer GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K951075 · S & C Polymer GmbH · Dental device
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Mar 1995
Decision
22d
Days
Class 2
Risk

K951075 is an FDA 510(k) clearance for the S & C VINYL POLYSILOXANE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Elmshorn, DE). The FDA issued a Cleared decision on March 31, 1995 after a review of 22 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.

FDA 510(k) Submission Details - K951075

510(k) Number K951075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date March 31, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 128d · This submission: 22d
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 359
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K951075.
RAMITEC PENTA
K952693 · Espe GmbH & Co. Kg. · Aug 1995
PERMADYNE GARANT 2:1
K953374 · Espe GmbH & Co. Kg. · Aug 1995
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · Espe GmbH & Co. Kg. · Jul 1995
GC SURFLEX F
K943388 · GC America, Inc. · Sep 1994
THIXOFLEX
K935896 · Zhermack Dental Production · Sep 1994
ELITE PUTTY HARD
K931242 · Zhermack Dental Production · Aug 1994