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2026 data FDA MAUDE openFDA FDA Class I

Handpiece, Air-Powered, Dental

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4200 (Dental panel).

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FDA MAUDE casebook

openFDA event book Handpiece, Air-Powered, Dental LIGHT-BOOK · MAUDE

#491 of 1000 · 2,071 reports · 1992–2026

  • BOOK 2,071 reports
  • RANK #491 of 1000
  • DEATH 0 death-typed
  • INJ 469 injury-typed
  • MALF 1,566 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 157
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented (5 report gap)

Handpiece, Air-Powered, Dental sits #491 of 1000 among tracked device types with 2,071 MAUDE reports spanning 1992–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Handpiece, Air-Powered, Dental carries 75.6% MALFUNCTION-coded reports, 10.8pp 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 22.6% corpus 30.3% · below corpus mean (-7.6 pp)
  • MALF 75.6% corpus 64.8% · above corpus mean (+10.8 pp)

Lead product-problem code Overheating of Device is 38% of coded problems · Top event location is 54% of location-tagged rows .

Handpiece, Air-Powered, Dental in the event-volume neighbourhood

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

reports

What this shows Handpiece, Air-Powered, Dental carries 2,071 MAUDE reports, ranked #491 of 1000.

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

Event Types

Malfunction 1,566 (75.6%)
Injury 469 (22.6%)
Other 22 (1.1%)
14 (0.7%)

Patient Outcomes

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

1,271 (61.0%)
Other 573 (27.5%)
Required Intervention 181 (8.7%)
Hospitalization 26 (1.2%)
R 17 (0.8%)
Disability 6 (0.3%)
O 4 (0.2%)
Life Threatening 4 (0.2%)

Top Product Problems

Overheating of Device 836
Detachment of Device or Device Component 454
Detachment Of Device Component 195
Temperature Problem 108
Component Falling 106
Material Separation 91
Mechanical Problem 76
Insufficient Device Problem Information 66
Dent in Material 38
Use of Device Problem 37
Device, or device fragments remain in patient 31
Device Slipped 23
Improper or Incorrect Procedure or Method 22
Break 19
Device Maintenance Issue 17
Device Handling Problem 15
Unknown (for use when the device problem is not known) 14
Adverse Event Without Identified Device or Use Problem 12
Migration or Expulsion of Device 12
Device Operates Differently Than Expected 11

Yearly Trend

92
1992: 2
94
1994: 2
95
1995: 3
96
1996: 3
97
1997: 11
98
1998: 3
00
2000: 2
01
2001: 1
02
2002: 22
03
2003: 65
04
2004: 140
05
2005: 8
06
2006: 15
07
2007: 13
08
2008: 19
09
2009: 40
10
2010: 78
11
2011: 96
12
2012: 97
13
2013: 61
14
2014: 73
15
2015: 87
16
2016: 122
17
2017: 153
18
2018: 81
19
2019: 117
20
2020: 94
21
2021: 123
22
2022: 157
23
2023: 116
24
2024: 104
25
2025: 83
26
2026: 80

Reports in 2025 (83) held close to the prior two-year average of 110.

Related Entities for Handpiece, Air-Powered, Dental

Event Locations

1,122 (54.2%)
I 681 (32.9%)
OTHER 139 (6.7%)
OUTPATIENT TREATMENT FACILITY 83 (4.0%)
NO INFORMATION 22 (1.1%)
INVALID DATA 8 (0.4%)
HOSPITAL 6 (0.3%)
UNKNOWN 5 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Nationwide devices with a comparable report-volume footprint

Handpiece, Air-Powered, Dental carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,071 here).

Prosthesis 2,066 Continuous Glucose Monitor Retrospective Da… 2,060 Catheter, Percutaneous, Cutting/Scoring 2,083 Ligator, Hemorrhoidal 2,058

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Handpiece, Air-Powered, Dental 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 Handpiece, Air-Powered, Dental; 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.