510(k) · Cleared
ClearedTalon and Revere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talon Acrylics, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Aug 2, 2007 as substantially equivalent to K910795 (Comfort Acrylics Co., 1991) and 1 other predicate after a 91-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Aug 2, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900799 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K073040SMH Flex SSmh Biomaterial AG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900799 | Comfort Acrylics Pliable Denture Liners & Splints | Comfort Acrylics Co. | 1990 | — |
| 0 (this device) | K071245 | Talon and Revere | Talon Acrylics, Inc. | 2007 | — |
| +1 | K073040 | SMH Flex S | Smh Biomaterial AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K910795 | Comfor-Dent Denture LinerSummary page 1…quired by 807.92(a)(3) Two (2) of the legally marketed predicate devices identified by the submitter are the presently marketed Comfor-dent Denture Liner, K910795, and Comfort Acrylics Pliable Denture Liners and Splints, K900799, both devices also manufactured by Comfort Acryli… | 1991 |
| * | K900799 | Comfort Acrylics Pliable Denture Liners & SplintsSummary page 1…devices identified by the submitter are the presently marketed Comfor-dent Denture Liner, K910795, and Comfort Acrylics Pliable Denture Liners and Splints, K900799, both devices also manufactured by Comfort Acrylics Company (now "Inc.), 2103 NE 272nd Ave, Camas, WA. Both predica… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073040 | SMH Flex S | 2007 | 0 |
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 2 ancestors has a recall.
- Of its descendants, K073040 (Smh Biomaterial AG, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
TALON and REVERE are a moldable acrylic compound for use in the fabrication, of TMJ/D Splints / Night Guards / Anti-Bruxism Guards / Mouth Guards / Sleep Apnea Anti-Snore Appliances / Liners, and/or Relines for Complete and Partial Dentures / Gaskets for Overdentures / and other dental prostheses device appliances as prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071245: Talon and Revere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071245
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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