510(k) · Cleared
ClearedOBA-MCP, Orthodontic Bracket Adhesive with MCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Jan 17, 2018 as substantially equivalent to K911286 (Pulpdent Corp., 1991) and 2 other predicates after a 111-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 17, 2018
- Review
- 111 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K880393 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880393 Transbond Light Cured Orthodontic AdhesiveUnitek Corp. · 1988
- This deviceK173020 OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880393 | Transbond Light Cured Orthodontic Adhesive | Unitek Corp. | 1988 | — |
| 0 (this device) | K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K911286 | Pulpdent Orthodontic Bracket AdhesiveSummary page 4…Name: Orthodontic Bracket Adhesive FDA Product Code: DYH; 21 CFR Part 872.3750 PREDICATE DEVICE: PULPDENT OBA-Orthodontic Bracket Adhesive, Pulpdent Corporation, K911286 REFERENCE DEVICE: PULPDENT Solo Flowable Composite with MCP, Pulpdent Corporation, K153249 ADDITIONAL PREDICATE DEVICES: Comp… | 1991 |
| * | K880393 | Transbond Light Cured Orthodontic AdhesiveSummary page 4…able chemical compositions for the below referenced devices can be found in the Safety Data Sheets for the each product. 3M Unitek Transbond XT Light Cure Adhesive, 3M, K880393 (file 046 in the e-copy) GC Fuji ORTHO LC Liquid, Fuji, K950556 (file 045 in the e-copy) DESCRIPTION: PULPDENT OBA-MCP is a li… | 1988 |
| * | K950556 | Fuji Ortho LCSummary page 4…e found in the Safety Data Sheets for the each product. 3M Unitek Transbond XT Light Cure Adhesive, 3M, K880393 (file 046 in the e-copy) GC Fuji ORTHO LC Liquid, Fuji, K950556 (file 045 in the e-copy) DESCRIPTION: PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite containing modified calci… | 1995 |
| † | K153249 | Pulpdent Solo Flowable Composite with MCP | 2016 |
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?
- None of the 3 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. 2018, 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?
PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct and indirect bonding of orthodontic brackets. For dental professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173020: OBA-MCP, Orthodontic Bracket Adhesive with MCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173020
Report an extraction error
Are you the manufacturer?
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