510(k) · Cleared

Cleared

BZF-29

K200682510(k) TraditionalCleared Oct 2, 2020200-day reviewClass II21 CFR 872.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GC America, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Oct 2, 2020 as substantially equivalent to K143140 (GC America, Inc., 2015) after a 200-day review. Its family tree reaches back 2 generations to 2008.

Decided: Oct 2, 2020
Review: 200 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K082768 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK082768 G-Bond PlusGC America, Inc. · 2008
1 generation backK143140 G-Premio BONDGC America, Inc. · 2015
This deviceK200682 BZF-29GC America, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K082768	G-Bond Plus	GC America, Inc.	2008	—
−1	K143140	G-Premio BOND	GC America, Inc.	2015	—
0 (this device)	K200682	BZF-29	GC America, Inc.	2020	—

FIG. 1 — Lineage of K200682, 2008–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KLE device

#1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K143140	G-Premio BOND Summary page 4 …e Devices: Product Applicant 510(k) No. Code No Predicate Decision Date G-Premio BOND GC America Inc. K143140 KLE Primary 04/20/2015 4. Description of Device: BZF-29 is a two component, light-cured bonding a…	GC America, Inc.	2015	—

Also cleared against K143140: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 6.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K143140.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	71	2	18
2008	3	66	0	9
2009	7	79	1	11
2010	8	93	1	13
2011	10	100	0	69
2012	5	66	0	176
2013	11	115	0	248
2014	6	120	0	260
2015	10	118	0	100
2016	3	148	1	47
2017	4	171	1	42
2018	8	124	0	31
2019	6	143	0	20
2020	6	195	0	6
2021	4	163	0	6
2022	8	98	0	7
2023	6	75	0	7
2024	7	61	1	12
2025	3	149	0	3
2026	7	84	0	—

What is it indicated for?

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for: Bonding of light cured composites and acid modified composites (compomers) to tooth structure. Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured. Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing. Intraoral repairs of all ceramic crowns (except…

Read the full statement (103 words)

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for:

Bonding of light cured composites and acid modified composites (compomers) to tooth structure.

Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured.

Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.

Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites.

Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.

Treatment of hypersensitive teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200682: BZF-29.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200682

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026