Cleared Traditional

K800485 - VINYL POLYSILOXANE IMPRESSION MATERIAL

K800485 is the FDA 510(k) clearance for VINYL POLYSILOXANE IMPRESSION MATERIAL by 3M Company. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800485 · 3M Company · Dental device
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Mar 1980
Decision
14d
Days
Class 2
Risk

K800485 is an FDA 510(k) clearance for the VINYL POLYSILOXANE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on March 18, 1980 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 3M Company devices

Submission Details

510(k) Number K800485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date March 18, 1980
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.

Device Classification

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 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K800485.
SYBRON/KERR MIRROR 3
K820183 · Sybron Corp. · Feb 1982
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
SUPERSIL
K800548 · Harry J. Bosworth Co. · Mar 1980
SILAGUM
K792363 · Parkell, Inc. · Jan 1980
ZYLOX
K782139 · Premier Dental Products Co. · Feb 1979