Cleared Traditional

CONCISE 2 SMALL PARTICLE LIGHT CURVED (K832834) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832834 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
41d
Days
Class 2
Risk

K832834 is an FDA 510(k) clearance for the CONCISE 2 SMALL PARTICLE LIGHT CURVED. 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 29, 1983 after a review of 41 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 3M Company devices

Submission Details

510(k) Number K832834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date September 29, 1983
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 51
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K832834.
GLOSSY COAT (15ML)
K254091 · YAMAHACHI DENTAL MFG., Co. · Apr 2026
ID LIGHT CURE SYSTEM
K250804 · Id Korea Co., Ltd. · Jun 2025
visio.lign color, visio.lign shield
K240735 · Bredent GmbH & Co. KG · Dec 2024
RODIN Palette Naturalizing Kit
K223365 · Belport Company, Inc., Gingi-Pak · Mar 2023
VITA Akzent LC
K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Nov 2021
Nano Varnish, Plaquit, Lightpaint on Surface
K162408 · Dreve Dentamid GmbH · Apr 2018