Cleared Traditional

K933612 - JEDENTAL

Also marketed or referenced as:
PCA CEMENT (POLYCARBOXYLATE CEMENT)

K933612 is an FDA 510(k) clearance for JEDENTAL, manufactured by Jedental Co., Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K933612 · Jedental Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
220d
Days
Class 2
Risk

K933612 is an FDA 510(k) clearance for the JEDENTAL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Jedental Co., Inc. (Southampton, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 220 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 Jedental Co., Inc. devices

FDA 510(k) Submission Details - K933612

510(k) Number K933612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date February 24, 1994
Days to Decision 220 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
93d slower than avg
Panel avg: 127d · This submission: 220d
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 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K933612.
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
GRANITEC IONOMER RESIN CEMENT
K940546 · Confi-Dental Products Co. · Apr 1994
PANAVIA 21
K933030 · Kuraray Co. · Feb 1994
BISCO COMPOSITE
K940030 · Bisco, Inc. · Feb 1994
FLEXI-FLOW CEMENT NATURAL
K922249 · Essential Dental Systems, Inc. · Jan 1994
FLEXI-FLOW CEMENT WITH TITANIUM
K922250 · Essential Dental Systems, Inc. · Jan 1994