Cleared Traditional

K131212 - PREMIER CERAMIC PRIMER (FDA 510(k) Clearance)

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

K131212 · Premier Dental Products Co. · Dental device
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Aug 2013
Decision
119d
Days
Class 2
Risk

K131212 is an FDA 510(k) clearance for the PREMIER CERAMIC PRIMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on August 26, 2013 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 K131212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2013
Decision Date August 26, 2013
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 418
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K131212.
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