Cleared Traditional

K033309 - PREMIER IMPLANT CEMENT, MODEL 3001450

K033309 is an FDA 510(k) clearance for PREMIER IMPLANT CEMENT, manufactured by Premier Dental Products Co.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K033309 · Premier Dental Products Co. · Dental device
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Jan 2004
Decision
104d
Days
Class 2
Risk

K033309 is an FDA 510(k) clearance for the PREMIER IMPLANT CEMENT, MODEL 3001450. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Belton, US). The FDA issued a Cleared decision on January 26, 2004 after a review of 104 days - within the typical 510(k) review window.

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 Premier Dental Products Co. devices

FDA 510(k) Submission Details - K033309

510(k) Number K033309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date January 26, 2004
Days to Decision 104 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
23d faster than avg
Panel avg: 127d · This submission: 104d
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 371
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K033309.
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004
RIVA LUTING
K040393 · Southern Dental Industries, Inc. · Apr 2004
PULPDENT VLC RESIN CEMENT
K040236 · Pulpdent Corporation · Apr 2004
PANAVIA F 2.0
K032455 · Kuraray Medical, Inc. · Nov 2003
MULTILINK
K032470 · Ivoclar Vivadent, Inc. · Nov 2003
BISCEM GI
K032597 · Bisco, Inc. · Nov 2003