510(k) Report

510(k) · Cleared

Cleared

Bruxtrak Material

K974160510(k) TraditionalCleared Mar 11, 1998126-day reviewClass II21 CFR 872.3760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bruxcare, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Mar 11, 1998 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Mar 11, 1998
Review
126 days
Class
Class II
Product code
EBI
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K974160Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All EBI devices

EBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBI

11in 2025

2007: 102008: 62009: 32010: 42011: 112012: 32013: 52014: 52015: 92016: 72017: 82018: 52019: 42020: 62021: 42022: 112023: 112024: 92025: 112026 (partial year): 7
2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007: 53 days median2008: 124 days median2009: 234 days median2010: 95 days median2011: 113 days median2012: 85 days median2013: 135 days median2014: 102 days median2015: 106 days median2016: 147 days median2017: 196 days median2018: 158 days median2019: 127 days median2020: 283 days median2021: 99 days median2022: 154 days median2023: 96 days median2024: 90 days median2025: 79 days median2026 (partial year): 87 days median
2007high 283 (2020) · low 53 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBI

2in 2022

2018: 22022: 2
2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBI

34in 2025

2007: 72008: 22009: 52010: 42011: 62012: 92013: 52014: 92015: 82016: 92017: 22018: 22019: 102020: 82021: 252022: 22023: 132024: 12025: 34
2007high 34 (2025) · low 1 (2024)2025

MAUDE reports naming product code EBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007105307
2008612402
2009323405
201049504
20111111306
201238509
2013513505
2014510209
2015910608
2016714709
2017819602
2018515822
20194127010
2020628308
2021499025
20221115422
20231196013
202499001
20251179034
20267870—

What is it indicated for?

BruxTrak™ material is intended for construction of temporary occlusal splints. When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following: Temporarily protect the teeth or dental work from damage due to teeth grinding Promote patient awareness of oro-myofacial habits, such as bruxism. Aid the dentist in locating occlusal areas of current wear Aid the dentist in evaluating…

Read the full statement (109 words)

BruxTrak™ material is intended for construction of temporary occlusal splints.

When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following:

Temporarily protect the teeth or dental work from damage due to teeth grinding

Promote patient awareness of oro-myofacial habits, such as bruxism.

Aid the dentist in locating occlusal areas of current wear

Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits

Aid the dentist in differentiating between historical tooth wear and current grinding activity.

Provide a physical record of a patient's grinding activity for a certain time period.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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https://510kreport.com/device/K974160 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974160: Bruxtrak Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974160

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026