Cleared Traditional

K781293 - RESTORATIVE SYSTEM PROFILE

K781293 is an FDA 510(k) clearance for RESTORATIVE SYSTEM PROFILE, manufactured by The S. S. White Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K781293 · The S. S. White Co. · Dental device
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Aug 1978
Decision
22d
Days
Class 2
Risk

K781293 is an FDA 510(k) clearance for the RESTORATIVE SYSTEM PROFILE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by The S. S. White Co. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1978 after a review of 22 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 The S. S. White Co. devices

FDA 510(k) Submission Details - K781293

510(k) Number K781293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1978
Decision Date August 18, 1978
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 128d · This submission: 22d
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 819
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K781293.
CONTACT RESIN
K790439 · Vivadent (Usa), Inc. · Apr 1979
ISOPLAST
K781787 · Vivadent (Usa), Inc. · Dec 1978
AUROFIL
K781687 · Wallace A. Erickson & Co. · Dec 1978
ZYTRON
K780796 · Premier Dental Products Co. · Jun 1978
NEW RESTODENT
K780965 · Lee Pharmaceuticals · Jun 1978
ESTILUX MICROFILL
K780832 · Degussa Dental, Inc. · Jun 1978