2026 data FDA MAUDE openFDA FDA Class II

Device, Anti-Snoring

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §872.5570 (Dental panel).

FDA MAUDE casebook

openFDA event book Device, Anti-Snoring LIGHT-BOOK · MAUDE

#440 of 1000 · 2,628 reports · 2003–2026

  • BOOK 2,628 reports
  • RANK #440 of 1000
  • DEATH 1 death-typed
  • INJ 728 injury-typed
  • MALF 1,878 malfunction
  • SPAN 2003–2026
  • PEAK 2026: 761
  • PHOTO Handpiece

Nearest event-volume peer: Handpiece, Contra- And Right-Angle Attachment, Dental (1 report gap)

Device, Anti-Snoring sits #440 of 1000 among tracked device types with 2,628 MAUDE reports spanning 2003–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Device, Anti-Snoring carries 71.5% MALFUNCTION-coded reports, 6.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 27.7% corpus 30.3% · below corpus mean (-2.6 pp)
  • MALF 71.5% corpus 64.8% · above corpus mean (+6.6 pp)

Lead product-problem code Break is 35% of coded problems · Lead manufacturer PRISMATIK DENTALCRAFT, INC. accounts for 73% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .

Device, Anti-Snoring in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Device, Anti-Snoring carries 2,628 MAUDE reports, ranked #440 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,878 (71.5%)
Injury 728 (27.7%)
13 (0.5%)
Other 8 (0.3%)
Death 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,859 (71.5%)
Required Intervention 450 (17.3%)
Other 237 (9.1%)
Life Threatening 20 (0.8%)
R 11 (0.4%)
Disability 9 (0.3%)
Hospitalization 4 (0.2%)
O 3 (0.1%)
L 2 (0.1%)
S 2 (0.1%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Break 1,045
Detachment of Device or Device Component 646
Extrusion 244
Adverse Event Without Identified Device or Use Problem 226
Migration or Expulsion of Device 210
Fracture 161
Insufficient Device Problem Information 80
Patient Device Interaction Problem 72
Detachment Of Device Component 50
Biocompatibility 39
Patient-Device Incompatibility 31
Crack 30
Material Fragmentation 17
Material Separation 17
Material Integrity Problem 16
Device Operates Differently Than Expected 13
Unintended Movement 13
Device Slipped 12
Fitting Problem 12
Product Quality Problem 12

Yearly Trend

03
2003: 2
04
2004: 2
05
2005: 3
06
2006: 3
08
2008: 1
09
2009: 11
10
2010: 7
11
2011: 69
12
2012: 445
13
2013: 72
14
2014: 49
15
2015: 28
16
2016: 18
17
2017: 32
18
2018: 61
19
2019: 56
20
2020: 24
21
2021: 49
22
2022: 40
23
2023: 50
24
2024: 185
25
2025: 660
26
2026: 761

Reports rose to 660 in 2025, up from an average of 118 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Device, Anti-Snoring

Event Locations

2,176 (82.8%)
I 385 (14.6%)
HOME 27 (1.0%)
NO INFORMATION 24 (0.9%)
HOSPITAL 5 (0.2%)
UNKNOWN 4 (0.2%)
OTHER 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare PRISMATIK DENTALCRAFT, INC. vs MEDTRONIC XOMED, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Anti-Snoring: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,628 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Anti-Snoring are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Device, Anti-Snoring; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.