Cleared Traditional

K200682 - BZF-29

K200682 is an FDA 510(k) clearance for BZF-29, manufactured by GC America, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K200682

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.

KLE Device Classification - Class 2, Special Controls

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 372
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