Positioner, Tooth, Preformed
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 §872.5525 (Dental panel).
FDA MAUDE casebook
openFDA event book Positioner, Tooth, Preformed LIGHT-BOOK · MAUDE
#538 of 1000 · 1,674 reports · 2001–2026
- BOOK 1,674 reports
- RANK #538 of 1000
- DEATH 0 death-typed
- INJ 1,519 injury-typed
- MALF 153 malfunction
- SPAN 2001–2026
- PEAK 2026: 713
- PHOTO Catheter
Nearest event-volume peer: Catheter, Percutaneous, Neurovasculature (5 report gap)
Positioner, Tooth, Preformed sits #538 of 1000 among tracked device types with 1,674 MAUDE reports spanning 2001–2026. 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 →
Injury-coded reports run above the device-type norm
Positioner, Tooth, Preformed carries 90.7% INJURY-coded reports, 60.4pp 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 90.7% corpus 30.3% · above corpus mean (+60.4 pp)
- MALF 9.1% corpus 64.8% · below corpus mean (-55.7 pp)
Lead product-problem code Sharp Edges is 25% of coded problems · Lead manufacturer STRAIGHT SMILE LLC accounts for 66% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .
Positioner, Tooth, Preformed in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Positioner (this)
Positioner, Tooth, Preformed
1,674 reports
- Catheter
Catheter, Percutaneous, Neurovasculature
1,669 reports
- Assay
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
1,668 reports
- Laryngoscope
Laryngoscope, Endoscope
1,664 reports
- Adhesive
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
1,663 reports
- Processor
Processor, Tissue, Automated
1,657 reports
What this shows Positioner, Tooth, Preformed carries 1,674 MAUDE reports, ranked #538 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 459 in 2025, up from an average of 190 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Positioner, Tooth, Preformed
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Positioner, Tooth, Preformed 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 (1,674 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Positioner, Tooth, Preformed 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 Positioner, Tooth, Preformed; 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.