Cleared Traditional

K822869 - COMMAND BONDING RESIN/GLAZE/OPAQUER

K822869 is the FDA 510(k) clearance for COMMAND BONDING RESIN/GLAZE/OPAQUER by Sybron Corp.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K822869 · Sybron Corp. · Dental device

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Oct 1982

Decision

16d

Days

Class 2

Risk

K822869 is an FDA 510(k) clearance for the COMMAND BONDING RESIN/GLAZE/OPAQUER. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Corp. devices

Submission Details

510(k) Number	K822869 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 1982
Decision Date	October 13, 1982
Days to Decision	16 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

111d faster than avg

Panel avg: 127d · This submission: 16d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	EBD Coating, Filling Material, Resin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 872.3310

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 - EBD Coating, Filling Material, Resin

All 38

Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K822869.

OPAQUE COATING & SURFACE STAIN

K840751 · Dentsply Intl. · May 1984

CONCISE 2 SMALL PARTICLE LIGHT CURVED

K832834 · 3M Company · Sep 1983

CBM, CORE BUILD-UP MATERIAL

K823732 · Scientific Pharmaceuticals, Inc. · Dec 1982

CONCLUDE COMPOSITE LUTING CEMENT

K822714 · 3M Company · Sep 1982

MYERSON/KENSON GP POLYMER

K813328 · Howmedica Corp. · Feb 1982

SCI-PHARM PAINT-ON RESTORATIVE

K791067 · Scientific Pharmaceuticals, Inc. · Aug 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822869

Sybron Corp.

Mchenry, IL · US

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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