Cleared Traditional

K926070 - PRIMODENT ACRYLIC TEETH

K926070 is an FDA 510(k) clearance for PRIMODENT ACRYLIC TEETH, manufactured by I.T.C. Ent.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 443-day FDA review.

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

FDA 510(k) Submission Details - K926070

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.

ELM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ELM Denture, Plastic, Teeth

All 35
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K926070.
NATURA DENTURE TEETH
K984134 · Davis Schottlander & Davis, Ltd. · Feb 1999
ENIGMA DENTURE TEETH
K984128 · Davis Schottlander & Davis, Ltd. · Feb 1999
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
COMPATIT R
K913582 · Wilde-USA, Inc. · Jun 1993
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992