510(k) · Cleared
ClearedNti Clenching Suppression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · MQC Mouthguard, Prescription
Cleared on Jul 15, 1998 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 39 later devices descend from it.
- Decided
- Jul 15, 1998
- Review
- 76 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 3 citing it directly.
- This deviceK981546 Nti Clenching Suppression SystemHeraeus Kulzer, Inc. · 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 · cites it directly · 11 of its ownK040315 Myohealth Clenching InhibitorMci-Myohealth Systems · 2004
- Descendant · 4 generations on · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · 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
- K040315Myohealth Clenching InhibitorMci-Myohealth Systems · 2004 · cites it directly11descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981546 | Nti Clenching Suppression System | Heraeus Kulzer, Inc. | 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 | — |
| +1 | K040315 | Myohealth Clenching Inhibitor | Mci-Myohealth Systems | 2004 | — |
| +4 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 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 15.4 · 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? (39)
See all 393 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, 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?
For the prevention of chronic tension and temporal mandibular joint syndrome that is caused by chronic clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
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/K981546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981546: Nti Clenching Suppression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981546
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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