Cleared Traditional

K982148 - PRODIGY 2

K982148 is an FDA 510(k) clearance for PRODIGY 2, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K982148 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
43d
Days
Class 2
Risk

K982148 is an FDA 510(k) clearance for the PRODIGY 2. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on July 31, 1998 after a review of 43 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K982148

510(k) Number K982148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1998
Decision Date July 31, 1998
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
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 760
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K982148.
ESTENIA
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K982201 · Foremost Dental Mfg., Inc. · Aug 1998
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K981813 · Foremost Dental Mfg., Inc. · Jul 1998
ARISTON PHC
K981264 · Ivoclar USA, Inc. · Jul 1998