Cleared Traditional

K912991 - WILDE AUXILIARIES

K912991 is an FDA 510(k) clearance for WILDE AUXILIARIES, manufactured by Wilde-USA, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K912991 · Wilde-USA, Inc. · Dental device
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Dec 1991
Decision
164d
Days
Class 2
Risk

K912991 is an FDA 510(k) clearance for the WILDE AUXILIARIES. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Naperville, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 164 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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-USA, Inc. devices

FDA 510(k) Submission Details - K912991

510(k) Number K912991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date December 19, 1991
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 194
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K912991.
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992
PALADUR
K915898 · Heraeus Kulzer, Inc. · Sep 1992
SR-IVOCAP PLUS
K915377 · Ivoclar North America, Inc. · Jan 1992
PROBASE HOT AND PROBASE COLD
K913655 · Ivoclar North America, Inc. · Oct 1991
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
K913698 · Heraeus Kulzer, Inc. · Oct 1991
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · Heraeus Kulzer, Inc. · Oct 1991