510(k) · Cleared
ClearedTP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tp Orthodontics, Inc. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Oct 14, 2022 as substantially equivalent to K160782 (American Orthodontics, 2016) and 2 other predicates after a 291-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Oct 14, 2022
- Review
- 291 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K031915 (2003). 6 ancestors in all, the oldest K880393 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK031915 Pulpdent Etch-Rite RoyalePulpdent Corporation · 2003
- 2 generations backK152110 e-1 etchantsE Dental Products · 2015
- 1 generation backK172953 Acid EtchantAmerican Orthodontics · 2018
- This deviceK214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics…Tp Orthodontics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031915 | Pulpdent Etch-Rite Royale | Pulpdent Corporation | 2003 | — |
| −2 | K152110 | e-1 etchants | E Dental Products | 2015 | — |
| −1 | K172953 | Acid Etchant | American Orthodontics | 2018 | — |
| 0 (this device) | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied… | Tp Orthodontics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2002 | 1 | 0 |
| 2016 | 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 DYH? 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 DYH device
- #1 K261840 BracePaste Prime Plusscore 13.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K160782 | BracePaste AdhesiveSummary page 4…vice Applicant 510(k) Number BracePaste Adhesive American Orthodontics K160782 Secondary Predicate Devices Device Applicant 510(k) Number… | 2016 |
| * | K020394 | Apc Plus AdhesiveSummary page 4…vice Applicant 510(k) Number APC Plus Adhesive 3M Unitek Corp. K020394 Acid Etchant American Orthodontics K172953 Reference Predicate Devices… | 2002 |
| * | K172953 | Acid EtchantSummary page 4…APC Plus Adhesive 3M Unitek Corp. K020394 Acid Etchant American Orthodontics K172953 Reference Predicate Devices Device Applicant 510(k) Number… | 2018 |
| † | K880393 | Transbond Light Cured Orthodontic Adhesive | 1988 |
| † | K113197 | Apc Flash-Free Adhesive | 2012 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All DYH devicesDYH Adhesive, Bracket And Tooth Conditioner, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DYH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYH
143in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYH
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYH
1in 2025
MAUDE reports naming product code DYH, 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 | 3 | 62 | 1 | 2 |
| 2008 | 6 | 72 | 0 | 1 |
| 2009 | 3 | 77 | 0 | 1 |
| 2010 | 4 | 96 | 0 | 5 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 3 | 82 | 0 | 3 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 5 | 135 | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 143 | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 3 | 87 | 0 | — |
What is it indicated for?
TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.
TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214054
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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