Cleared Traditional

K912001 - CONVERTRAY, MODIFICATION

K912001 is an FDA 510(k) clearance for CONVERTRAY, manufactured by Wilde Dental (Usa). The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K912001 · Wilde Dental (Usa) · Dental device
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Jan 1992
Decision
267d
Days
Class 2
Risk

K912001 is an FDA 510(k) clearance for the CONVERTRAY, MODIFICATION. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Wilde Dental (Usa) (Chicago, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 267 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Wilde Dental (Usa) devices

FDA 510(k) Submission Details - K912001

510(k) Number K912001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date January 09, 1992
Days to Decision 267 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 330
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K912001.
CORRECTED-V.P.S.
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VITA CEREC SET AND VITA CEREC BLOCS
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CORRECT-S.I.M.
K914437 · Jeneric/Pentron, Inc. · Jan 1992
MEMOSIL C.D.
K913537 · Heraeus Kulzer, Inc. · Oct 1991
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
K912485 · Coltene/Whaledent, Inc. · Jul 1991
CUTTERSIL MUCOSA
K910165 · Heraeus Kulzer, Inc. · Jun 1991