Cleared Traditional

SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET (K965083) - FDA 510(k) Clearance

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

K965083 · S.S. White Mfg., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
106d
Days
Class 2
Risk

K965083 is an FDA 510(k) clearance for the SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORM.... Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by S.S. White Mfg., Ltd. (Gloucester, GB). The FDA issued a Cleared decision on April 4, 1997 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all S.S. White Mfg., Ltd. devices

Submission Details

510(k) Number K965083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date April 04, 1997
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K965083.
3M M.G. MATERIAL
K981325 · 3M Company · Jun 1998
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL
K973781 · Dentsply Intl. · Dec 1997
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
K973782 · Dentsply Intl. · Dec 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · Dentsply Intl. · Mar 1997
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996