Cleared Traditional

K993710 - MODIFICATION OF PARAPOST CEMENT

K993710 is an FDA 510(k) clearance for MODIFICATION OF PARAPOST CEMENT, manufactured by Coltene/Whaledent, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K993710 · Coltene/Whaledent, Inc. · Dental device
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Dec 1999
Decision
48d
Days
Class 2
Risk

K993710 is an FDA 510(k) clearance for the MODIFICATION OF PARAPOST CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coltene/Whaledent, Inc. devices

FDA 510(k) Submission Details - K993710

510(k) Number K993710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1999
Decision Date December 21, 1999
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 344
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K993710.
GC FUJICEM
K001730 · GC America, Inc. · Jul 2000
CEMENT IT! UNIVERSAL C&B
K000173 · Jeneric/Pentron, Inc. · Feb 2000
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
K994261 · Ultradent Products, Inc. · Feb 2000
CARBOCEM ZINC POLYCARBOXYLATE CEMENT
K993324 · Scientific Pharmaceuticals, Inc. · Nov 1999
NEXUS 2
K992160 · Sybron Dental Specialties, Inc. · Aug 1999
BISTITE II SC
K991711 · Tokuyama America, Inc. · Jul 1999