Cleared Traditional

K031212 - TEMPORARY RESIN CEMENT

K031212 is an FDA 510(k) clearance for TEMPORARY RESIN CEMENT, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K031212 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
85d
Days
Class 2
Risk

K031212 is an FDA 510(k) clearance for the TEMPORARY RESIN CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 11, 2003 after a review of 85 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.

FDA 510(k) Submission Details - K031212

510(k) Number K031212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date July 11, 2003
Days to Decision 85 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
43d faster than avg
Panel avg: 128d · This submission: 85d
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 506
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K031212.
DESENS-IONOMER
K032175 · Milton Hodosh, M.D. · Oct 2003
COLTOSOL F
K031752 · Coltene/Whaledent, Inc. · Aug 2003
GLASIONOMER FX-II
K031467 · Shofu Dental Corp. · Jul 2003
POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
K030727 · Healex Products, Inc. · Jun 2003
RIVA-SELF CURE
K030516 · Southern Dental Industries, Inc. · Apr 2003
FIXOBRIDGE 3-CEMENT
K024287 · Advanced Healthcare , Ltd. · Mar 2003
K031212 · TEMPORARY RESIN CEMENT
Download PDF FDA Summary Parkell, Inc.