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2026 data FDA MAUDE openFDA FDA Class II

Agent, Tooth Bonding, 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 §872.3200 (Dental panel).

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FDA MAUDE casebook

openFDA event book Agent, Tooth Bonding, Resin LIGHT-BOOK · MAUDE

#632 of 1000 · 1,159 reports · 1994–2026

  • BOOK 1,159 reports
  • RANK #632 of 1000
  • DEATH 0 death-typed
  • INJ 1,084 injury-typed
  • MALF 30 malfunction
  • SPAN 1994–2026
  • PEAK 2014: 260
  • PHOTO Agent

Nearest event-volume peer: Agent, Bulking, Injectable For Gastro-Urology Use (1 report gap)

Agent, Tooth Bonding, Resin sits #632 of 1000 among tracked device types with 1,159 MAUDE reports spanning 1994–2026. 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 →

Injury-coded reports run above the device-type norm

Agent, Tooth Bonding, Resin carries 93.5% INJURY-coded reports, 63.2pp 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 93.5% corpus 30.3% · above corpus mean (+63.2 pp)
  • MALF 2.6% corpus 64.8% · below corpus mean (-62.2 pp)

Lead product-problem code Loss of or Failure to Bond is 17% of coded problems · Top event location is 63% of location-tagged rows .

Agent, Tooth Bonding, Resin in the event-volume neighbourhood

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

reports

What this shows Agent, Tooth Bonding, Resin carries 1,159 MAUDE reports, ranked #632 of 1000.

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

Event Types

Injury 1,084 (93.5%)
Malfunction 30 (2.6%)
Other 30 (2.6%)
15 (1.3%)

Patient Outcomes

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

Other 592 (37.8%)
R 387 (24.7%)
Required Intervention 341 (21.8%)
Life Threatening 114 (7.3%)
86 (5.5%)
L 13 (0.8%)
Congenital Anomaly 9 (0.6%)
Hospitalization 8 (0.5%)
S 6 (0.4%)
Disability 5 (0.3%)
Death 3 (0.2%)
O 2 (0.1%)

Top Product Problems

Loss of or Failure to Bond 218
Improper or Incorrect Procedure or Method 197
Insufficient Device Problem Information 179
Patient-Device Incompatibility 145
Failure To Adhere Or Bond 96
Adverse Event Without Identified Device or Use Problem 74
No Apparent Adverse Event 74
Appropriate Device Problem Term/Code Not Available 63
Unknown (for use when the device problem is not known) 50
Use of Device Problem 36
Device Operates Differently Than Expected 31
Incorrect, Inadequate or Imprecise Result or Readings 27
Detachment Of Device Component 20
Material Discolored 14
Replace 13
Device Handling Problem 12
Labelling, Instructions for Use or Training Problem 10
Reaction 10
Nonstandard Device 9
Device Issue 7

Yearly Trend

94
1994: 1
97
1997: 1
98
1998: 4
99
1999: 3
00
2000: 6
03
2003: 2
04
2004: 1
05
2005: 9
06
2006: 34
07
2007: 18
08
2008: 9
09
2009: 11
10
2010: 13
11
2011: 69
12
2012: 176
13
2013: 248
14
2014: 260
15
2015: 100
16
2016: 47
17
2017: 42
18
2018: 31
19
2019: 20
20
2020: 6
21
2021: 6
22
2022: 7
23
2023: 7
24
2024: 12
25
2025: 3
26
2026: 13

Reports fell to 3 in 2025, down from an average of 10 in the two years before.

Related Entities for Agent, Tooth Bonding, Resin

Event Locations

726 (62.6%)
I 202 (17.4%)
OTHER 186 (16.0%)
HOME 30 (2.6%)
NO INFORMATION 12 (1.0%)
INVALID DATA 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Agent, Tooth Bonding, Resin 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 (1,159 here).

Agent 1,158 Filter, Infusion Line 1,167 Holder, Ureteral Catheter 1,177 Spinal Pedicle Screw 1,178

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 Agent, Tooth Bonding, 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 Agent, Tooth Bonding, 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.