Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-26 | VAI | Voluntary action indicated | Practicon Inc | 3 |
| 2026-02-26 | VAI | Voluntary action indicated | Practicon Inc | 3 |
| 2017-01-24 | NAI | No action indicated | Practicon Inc | 0 |
| 2017-01-24 | NAI | No action indicated | Practicon Inc | 0 |
Similar devices
- CLEARFIL™ DC CORE PLUS Guide tip (L) KURARAY NORITAKE DENTAL INC.
- "6.5 Mixing Tips ""T-mixer"" 100-pack" DEN-MAT HOLDINGS, LLC
- "6.5 Mixing Tips ""T-mixer"" 50-Pack" DEN-MAT HOLDINGS, LLC
- "6.5 Mixing Tips ""T-mixer""" CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- "6.5 Mixing Tips ""T-mixer""" CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- "SCOTT'S PENTA TYPE MIX TIPS ""NEW"" RED 50/BX" SCOTT'S DENTAL SUPPLY L.L.C.
- 10:1 Dispenser - Pro-V C & B BISCO INC.
- 10:1 Mixing tips 15pk - Pro-V C&B BISCO INC.
- 16 Gauge Black Tips COSMEDENT, INC.
- 18 Gauge Pink Tips COSMEDENT, INC.
- 19 Gauge Silver Tips COSMEDENT, INC.
- 19G Blk Tip, 10eaPkg w/Label BISCO INC.
Select up to two to place side-by-side with this device.