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2025 data FDA MAUDE openFDA FDA Class II

Material, Tooth Shade, Resin

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 §872.3690 (Dental panel).

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FDA MAUDE casebook

openFDA event book Material, Tooth Shade, Resin LIGHT-BOOK · MAUDE

#679 of 1000 · 961 reports · 1997–2025

  • BOOK 961 reports
  • RANK #679 of 1000
  • DEATH 1 death-typed
  • INJ 924 injury-typed
  • MALF 21 malfunction
  • SPAN 1997–2025
  • PEAK 2013: 246
  • PHOTO Recorder

Nearest event-volume peer: Recorder, Magnetic Tape, Medical (1 report gap)

Material, Tooth Shade, Resin sits #679 of 1000 among tracked device types with 961 MAUDE reports spanning 1997–2025. 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 →

Injury-coded reports run above the device-type norm

Material, Tooth Shade, Resin carries 96.1% INJURY-coded reports, 65.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 96.1% corpus 30.3% · above corpus mean (+65.9 pp)
  • MALF 2.2% corpus 64.8% · below corpus mean (-62.6 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 26% of coded problems · Top event location is 65% of location-tagged rows .

Material, Tooth Shade, Resin in the event-volume neighbourhood

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

reports

What this shows Material, Tooth Shade, Resin carries 961 MAUDE reports, ranked #679 of 1000.

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

Event Types

Injury 924 (96.1%)
Malfunction 21 (2.2%)
Other 11 (1.1%)
4 (0.4%)
Death 1 (0.1%)

Patient Outcomes

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

Other 552 (40.3%)
R 400 (29.2%)
Required Intervention 352 (25.7%)
41 (3.0%)
Hospitalization 9 (0.7%)
O 4 (0.3%)
S 4 (0.3%)
Life Threatening 4 (0.3%)
Disability 3 (0.2%)

Top Product Problems

Appropriate Device Problem Term/Code Not Available 243
Device Contamination with Chemical or Other Material 116
Device Operates Differently Than Expected 90
Adverse Event Without Identified Device or Use Problem 66
Insufficient Device Problem Information 66
Patient-Device Incompatibility 63
Material Integrity Problem 59
Material Discolored 49
Loss of or Failure to Bond 45
Failure To Adhere Or Bond 26
Unknown (for use when the device problem is not known) 23
Break 15
Delamination 15
Leak/Splash 13
Nonstandard Device 12
Improper Chemical Reaction 11
Improper or Incorrect Procedure or Method 9
Contamination 7
Replace 7
Fracture 6

Yearly Trend

97
1997: 1
98
1998: 3
99
1999: 2
02
2002: 4
03
2003: 5
04
2004: 3
05
2005: 3
06
2006: 8
07
2007: 6
08
2008: 10
09
2009: 8
10
2010: 31
11
2011: 31
12
2012: 62
13
2013: 246
14
2014: 195
15
2015: 119
16
2016: 143
17
2017: 42
18
2018: 8
19
2019: 11
20
2020: 2
21
2021: 2
22
2022: 2
23
2023: 8
24
2024: 5
25
2025: 1

Reports in 2024 (5) held close to the prior two-year average of 5.

Related Entities for Material, Tooth Shade, Resin

Event Locations

628 (65.3%)
I 277 (28.8%)
OTHER 34 (3.5%)
NO INFORMATION 9 (0.9%)
UNKNOWN 6 (0.6%)
HOME 4 (0.4%)
HOSPITAL 1 (0.1%)
INVALID DATA 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Material, Tooth Shade, Resin: 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 (961 here).

Recorder, Magnetic Tape, Medical 962 Alarm, Conditioned Response Enuresis 965 Percutaneously Delivered Prostheses And Tri… 965 Pump, Portable, Aspiration 968

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Aligner, Sequential 1

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

Disclaimer: MAUDE figures for Material, Tooth Shade, Resin 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 Material, Tooth Shade, Resin; 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.