510(k) · Cleared
ClearedAccu-Bite Home Kit Discluder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jerome M. Simon · MQC Mouthguard, Prescription
Cleared on Oct 7, 1998 after a 208-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 34 later devices descend from it.
- Decided
- Oct 7, 1998
- Review
- 208 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 1 citing it directly.
- This deviceK980953 Accu-Bite Home Kit DiscluderJerome M. Simon · 1998
- Descendant · cites it directly · 33 of its ownK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- Descendant · 2 generations on · 20 of its ownK024261 Dental ProtectorDental Concepts, LLC · 2003
- Descendant · 3 generations on · 17 of its ownK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- Descendant · 4 generations on · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 5 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K014079DR. Hays Bite GuardInventive Resources, Inc. · 2002 · cites it directly33descendants
- K024261Dental ProtectorDental Concepts, LLC · 2003 · 2 generations on20descendants
- K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007 · 3 generations on17descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · 4 generations on10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980953 | Accu-Bite Home Kit Discluder | Jerome M. Simon | 1998 | — |
| +1 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| +2 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| +3 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| +4 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +5 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014079 | DR. Hays Bite Guard | 2002 | 33 |
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, K014079 (Inventive Resources, Inc., 2002) has gone furthest, with 33 descendants of its own.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980953: Accu-Bite Home Kit Discluder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980953
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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