Cleared Traditional

K033309 - PREMIER IMPLANT CEMENT, MODEL 3001450 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 504
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