Cleared Traditional

K822714 - CONCLUDE COMPOSITE LUTING CEMENT

K822714 is the FDA 510(k) clearance for CONCLUDE COMPOSITE LUTING CEMENT by 3M Company. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K822714 · 3M Company · Dental device
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Sep 1982
Decision
21d
Days
Class 2
Risk

K822714 is an FDA 510(k) clearance for the CONCLUDE COMPOSITE LUTING CEMENT. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on September 28, 1982 after a review of 21 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.

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Submission Details

510(k) Number K822714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date September 28, 1982
Days to Decision 21 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
106d faster than avg
Panel avg: 127d · This submission: 21d
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 32
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K822714.
CONCISE 2 SMALL PARTICLE LIGHT CURVED
K832834 · 3M Company · Sep 1983
CBM, CORE BUILD-UP MATERIAL
K823732 · Scientific Pharmaceuticals, Inc. · Dec 1982
COMMAND BONDING RESIN/GLAZE/OPAQUER
K822869 · Sybron Corp. · Oct 1982
MYERSON/KENSON GP POLYMER
K813328 · Howmedica Corp. · Feb 1982
SCI-PHARM PAINT-ON RESTORATIVE
K791067 · Scientific Pharmaceuticals, Inc. · Aug 1979
ANTERIOR/POSTERIOR RESTORATIVE, BOND
K791078 · Scientific Pharmaceuticals, Inc. · Aug 1979