Cleared Traditional

K972935 - SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL

K972935 is an FDA 510(k) clearance for SUPER-DENT INTERMEDIATE RESTORATIVE MAT..., manufactured by S.S. White Mfg., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K972935 · S.S. White Mfg., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
174d
Days
Class 2
Risk

K972935 is an FDA 510(k) clearance for the SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by S.S. White Mfg., Ltd. (Gloucester, GB). The FDA issued a Cleared decision on January 29, 1998 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 - K972935

510(k) Number K972935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1997
Decision Date January 29, 1998
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 386
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K972935.
FUJI II
K980682 · GC America, Inc. · Apr 1998
CLEARFIL DC CEMENT
K980232 · Kuraray Company, Ltd. · Feb 1998
COMPOLUTE APLICAP
K974458 · Espe Dental-Medizin GmbH & Co.Kg. · Feb 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
PULPDENT DENTASTIC UNO
K974014 · Pulpdent Corp. · Dec 1997