Cleared Traditional

K973201 - PROVI CEMENT

K973201 is an FDA 510(k) clearance for PROVI CEMENT, manufactured by S & C Polymer GmbH. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K973201 · S & C Polymer GmbH · Dental device
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Jun 1998
Decision
283d
Days
Class 2
Risk

K973201 is an FDA 510(k) clearance for the PROVI CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Harnredder, DE). The FDA issued a Cleared decision on June 5, 1998 after a review of 283 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 & C Polymer GmbH devices

FDA 510(k) Submission Details - K973201

510(k) Number K973201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1997
Decision Date June 05, 1998
Days to Decision 283 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 127d · This submission: 283d
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 345
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K973201.
LIQUID A
K981618 · Harry J. Bosworth Co. · Jul 1998
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
ARISTON PHC LINER
K981335 · Ivoclar North America, Inc. · Jul 1998
MIRACLE MIX CAPSULE
K981370 · GC America, Inc. · Jun 1998
JUMBO GLASS IONOMER CEMENT
K980568 · Centrix, Inc. · Apr 1998
PROTEC CEM.
K980922 · Ivoclar North America, Inc. · Apr 1998