Cleared Traditional

PRIMODENT ACRYLIC TEETH (K926070) - FDA 510(k) Clearance

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

K926070 · I.T.C. Ent. · Dental device
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Feb 1994
Decision
443d
Days
Class 2
Risk

K926070 is an FDA 510(k) clearance for the PRIMODENT ACRYLIC TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by I.T.C. Ent. (Marietta, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all I.T.C. Ent. devices

Submission Details

510(k) Number K926070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date February 17, 1994
Days to Decision 443 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
316d slower than avg
Panel avg: 127d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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.