Cleared Traditional

K852868 - WUNDERSHADE

K852868 is an FDA 510(k) clearance for WUNDERSHADE, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K852868 · Harry J. Bosworth Co. · Dental device
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Sep 1985
Decision
81d
Days
Class 2
Risk

K852868 is an FDA 510(k) clearance for the WUNDERSHADE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on September 27, 1985 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harry J. Bosworth Co. devices

FDA 510(k) Submission Details - K852868

510(k) Number K852868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1985
Decision Date September 27, 1985
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 758
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K852868.
SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE
K860627 · Scientific Pharmaceuticals, Inc. · Mar 1986
RENAMEL ESTHETIC RESTORATIVE SYSTEM
K854755 · Cosmedent, Inc. · Mar 1986
DENTAL CEMENT
K853431 · Dentsply Intl. · Oct 1985
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)
K853001 · Bisco, Inc. · Aug 1985
BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)
K853002 · Bisco, Inc. · Aug 1985
RESTORE*
K851929 · Johnson & Johnson Professionals, Inc. · Jul 1985