510(k) · Cleared
ClearedBright Bond Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss Co., Ltd. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 28, 2020 as substantially equivalent to K110302 (3M Espe AG, 2011) after a 280-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Oct 28, 2020
- Review
- 280 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K900510 (1990). 36 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 6 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 5 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 4 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 3 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 2 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 1 generation backK110302 Adhesive Exl-7593M Espe AG · 2011
- This deviceK200153 Bright Bond UniversalGenoss Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −6 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −5 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −4 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −3 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −1 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| 0 (this device) | K200153 | Bright Bond Universal | Genoss Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K110302 | Adhesive Exl-759Summary page 4…name: Bright Bond Universal Regulation description : Resin tooth bonding agent Classification name: Agent, Tooth Bonding, Resin 3. Predicate Device K110302 Scotchbond Universal 4. Description Bright Bond Universal is a light-cured dental adhesive that combines etchi… | 2011 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 36 ancestors has a recall of any class.
- 14 other devices also cite its predicate K110302.
How does its category compare?
All KLE devicesKLE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 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?
1) Direct bonding for light-cured composites to tooth surface
2) Bonding of dual-cured core build up composites to tooth surface
3) Intraoral repair of composite, PFM and ceramic restoration using cements
4) Sealing of tooth preparation for indirect restoration
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200153: Bright Bond Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200153
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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