Cleared Traditional

K913582 - COMPATIT R

K913582 is an FDA 510(k) clearance for COMPATIT R, manufactured by Wilde-USA, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 682-day FDA review.

K913582 · Wilde-USA, Inc. · Dental device
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Jun 1993
Decision
682d
Days
Class 2
Risk

K913582 is an FDA 510(k) clearance for the COMPATIT R. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 682 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.

FDA 510(k) Submission Details - K913582

510(k) Number K913582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date June 24, 1993
Days to Decision 682 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
554d slower than avg
Panel avg: 128d · This submission: 682d
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 45
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K913582.
OPTODENT/OPTOGNATH
K936058 · Spectrum Healthcare Group · May 1994
VERIDENT PLUS, OPTIFORM
K940244 · Lactona Corp. · May 1994
PRIMODENT ACRYLIC TEETH
K926070 · I.T.C. Ent. · Feb 1994
KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH
K931162 · King Dental Corp. · May 1993
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
DENTURE PLASTIC TEETH
K924526 · Austenal, Inc. · Nov 1992
K913582 · COMPATIT R
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