510(k) · Cleared
ClearedTemporary Crown Matrix Buttons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advantage Dental Products, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on Jul 13, 1990 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 13, 1990
- Review
- 165 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK900389 Temporary Crown Matrix ButtonsAdvantage Dental Products, Inc. · 1990
- Descendant · cites it directly · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 2 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
- Descendant · 3 generations on · 5 of its ownK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · 4 generations on · 3 of its ownK221369 FBCC Night GuardFbcc, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K082723GrindguardGrind Guard Technologies, LLC · 2009 · cites it directly10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 2 generations on9descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · 2 generations on6descendants
- K181099Bright GuardKoncept Innovators, LLC · 2019 · 3 generations on5descendants
- K221369FBCC Night GuardFbcc, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900389 | Temporary Crown Matrix Buttons | Advantage Dental Products, Inc. | 1990 | — |
| +1 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +2 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +2 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| +3 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +4 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K082723 (Grind Guard Technologies, LLC, 2009) has gone furthest, with 10 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K900389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900389: Temporary Crown Matrix Buttons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900389
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026