510(k) · Cleared
ClearedBond-PR™ Universal Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Dental Products Company · KLE Agent, Tooth Bonding, Resin
Cleared on Mar 3, 2026 as substantially equivalent to K192961 (3M Deutschland GmbH, 2019) after a 1-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Mar 3, 2026
- Review
- 1 day
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K900510 (1990). 37 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 7 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 6 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 5 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 4 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 3 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 2 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 1 generation backK192961 ADH193M Deutschland GmbH · 2019
- This deviceK260682 Bond-PR™ Universal AdhesivePremier Dental Products Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −7 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −6 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −5 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −4 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −3 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| −1 | K192961 | ADH19 | 3M Deutschland GmbH | 2019 | — |
| 0 (this device) | K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026 | — |
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 |
|---|---|---|---|
| * | K192961 | ADH19Summary page 5…E Regulation Number: 21 CFR §872.3200 Classification Name: Resin tooth bonding agent 3. Predicate Devices Product Applicant 510(k) No. Product Predicate Code ADH19- 3M K192961 KLE Primary Scotchbond Deutschland Universal Plus | GmbH 4. Device Description Premier's Bond-PR™ Universal Adhesive is a univ… | 2019 |
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 36 years and passes through 7 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 37 ancestors has a recall of any class.
- 1 other device also cites its predicate K192961.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Bonding of methacrylate-based light-, dual-, and self-cure composites, compomers, core build-up materials, sealants, and cements.
Intraoral repair of composite and compomer restorations
Root surface desensitization
Cavity sealing prior to amalgam or temporary restorations
Cementation of indirect restorations, including veneers, with resin cement
Intraoral repair of composite, ceramic, porcelain-fused-to-metal, zirconia and other all-ceramic restorations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260682: Bond-PR™ Universal Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260682
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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