Cleared Traditional

SEPTOSIL SILICONE FOR PRECISION IMPRESSION (K851388) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851388 · Specialites Septodont · Dental device
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May 1985
Decision
50d
Days
Class 2
Risk

K851388 is an FDA 510(k) clearance for the SEPTOSIL SILICONE FOR PRECISION IMPRESSION. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 50 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 Specialites Septodont devices

Submission Details

510(k) Number K851388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date May 29, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
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 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K851388.
HYDROPHILIC REPROSIL
K863288 · Dentsply Intl. · Dec 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485 · 3M Company · Mar 1980