Cleared Traditional

K200682 - BZF-29

K200682 is the FDA 510(k) clearance for BZF-29 by GC America, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K200682 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
200d
Days
Class 2
Risk

K200682 is an FDA 510(k) clearance for the BZF-29. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 2, 2020 after a review of 200 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all GC America, Inc. devices

Submission Details

510(k) Number K200682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2020
Decision Date October 02, 2020
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 127d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K200682.
Tokuyama Universal Bond II
K203760 · Tokuyama Dental Corporation · May 2021
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
K192913 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Jan 2021
Bright Bond Universal
K200153 · Genoss Co., Ltd. · Oct 2020
Light Cure Dental Adhesive
K201787 · Rizhao Huge Biomaterials Company, Ltd. · Sep 2020
EtchPro Etching Gel
K200462 · Belport Company, Inc., Gingi-Pak · Sep 2020
DiaPlus
K192392 · DiaDent Group International · May 2020