Cleared Traditional

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL (K972935) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K972935.
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · 3M Company · Sep 2000
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · 3M Company · Jul 1996