510(k) · Cleared
ClearedOral Bond
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steiner Laboratories · EMA Cement, Dental
Cleared on Jun 6, 2016 as substantially equivalent to K071484 (Glustitch, Inc., 2007) after a 672-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Jun 6, 2016
- Review
- 672 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810545 (1981). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK810545 Pca Periocare Periodontal DressingPulpdent Corp. of America · 1981
- 2 generations backK050658 Reso-Pac Periodontal DressingHager Worldwide, Inc. · 2005
- 1 generation backK071484 Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007
- This deviceK142130 Oral BondSteiner Laboratories · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810545 | Pca Periocare Periodontal Dressing | Pulpdent Corp. of America | 1981 | — |
| −2 | K050658 | Reso-Pac Periodontal Dressing | Hager Worldwide, Inc. | 2005 | — |
| −1 | K071484 | Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. | 2007 | — |
| 0 (this device) | K142130 | Oral Bond | Steiner Laboratories | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K071484 | Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Summary page 6…6 === PREDICATE DEVICE COMPARISON TABLE Oral Bond PeriAcryl 510K K142130 K071484 Intended use Temporary dental adhesive Temporary dental adhesive Materials 2-octyl cyanoacrylate… | 2007 |
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 35 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142130: Oral Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142130
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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