PDT, Inc.
PDT, INC. · Model R984 Composite & Crown Prep Kit · UDI-DI 00813677024503
2
510(k) clearances
7
Adverse events
8
Recalls
121
Facilities
Description
Kit Contains: (T0E15-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R166) Explorer 5 (R245) Mirror Handle (Cone-Socket) (R283) IPC- Non Coated (R286) G2 Thin Composite (R287) G3 Thin Composite (R363S) 113 Straight Serrated Cord Packer (R375) Mixing Spatula/Applicator (R386) 38-39 Excavator (T040) Tweezers COLLEGE (T046) Articulating Paper Forceps MILLER (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T319) Bur Block (T800) IRIS Scissors, curved
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.