Cleared Traditional

K810969 - ISOSIT C & B MATERIAL

K810969 is an FDA 510(k) clearance for ISOSIT C & B MATERIAL, manufactured by Bauer, Cheng & Associates, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K810969 · Bauer, Cheng & Associates, Inc. · Dental device
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May 1981
Decision
26d
Days
Class 2
Risk

K810969 is an FDA 510(k) clearance for the ISOSIT C & B MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bauer, Cheng & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 26 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 Bauer, Cheng & Associates, Inc. devices

FDA 510(k) Submission Details - K810969

510(k) Number K810969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1981
Decision Date May 05, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
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 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K810969.
SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM
K811427 · Harry J. Bosworth Co. · Aug 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · Kulzer, Inc. · Jul 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · 3M Company · Mar 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · Dentsply Intl. · Jan 1981
HYDROXYLATE DENTAL COMPOSITE RESTROATIVE
K802535 · Wallace A. Erickson & Co. · Dec 1980