Cleared Traditional

K912993 - WILDE DENTURE RESINS

K912993 is an FDA 510(k) clearance for WILDE DENTURE RESINS, 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 210-day FDA review.

K912993 · Wilde-USA, Inc. · Dental device
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Feb 1992
Decision
210d
Days
Class 2
Risk

K912993 is an FDA 510(k) clearance for the WILDE DENTURE RESINS. 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 February 3, 1992 after a review of 210 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.

FDA 510(k) Submission Details - K912993

510(k) Number K912993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date February 03, 1992
Days to Decision 210 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
82d slower than avg
Panel avg: 128d · This submission: 210d
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 305
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K912993.
PALADUR
K915898 · Heraeus Kulzer, Inc. · Sep 1992
CONVERBASE
K912990 · Wilde-USA, Inc. · Mar 1992
WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX
K920557 · Wilde-USA, Inc. · Mar 1992
SR-IVOCAP PLUS
K915377 · Ivoclar North America, Inc. · Jan 1992
WILDE AUXILIARIES
K912991 · Wilde-USA, Inc. · Dec 1991
PROBASE HOT AND PROBASE COLD
K913655 · Ivoclar North America, Inc. · Oct 1991
K912993 · WILDE DENTURE RESINS
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