Cleared Traditional

K965083 - SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET

K965083 is an FDA 510(k) clearance for SUPER-DENT ALGINATE, manufactured by S.S. White Mfg., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K965083

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
Combination Product No
PCCP Authorized No
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.

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 264
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K965083.
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
K972027 · Zhermack S.P.A. · Jul 1997
MEMOREG
K971155 · Heraeus Kulzer, Inc. · May 1997
HYDROFLEX
K970656 · GC America, Inc. · Apr 1997
KALGINATE IMPRESSION MATERIAL
K970594 · Teledyne Water Pik · Mar 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · Dentsply Intl. · Mar 1997
CUTTERSIL COMFORT
K965163 · Heraeus Kulzer, Inc. · Mar 1997