PDT, Inc.
PDT, INC. · Model R943 PDT Endo Kit · UDI-DI 00813677024985
3
510(k) clearances
14
Adverse events
7
Recalls
148
Facilities
Description
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (R311) DG 16 Explorer (R312) D11 Endo Spreader (R314) 1-3 Endo Plugger (R315) 5-7 Endo Plugger (R316) 9-11 Endo Plugger (R317) Glick 1 (R318) 31L Endo Excavator (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-01-07 | Hu-Friedy Mfg Co, Inc. | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, a |
| 2005-01-07 | Hu-Friedy Mfg Co, Inc. | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, a |
| 2005-01-07 | Hu-Friedy Mfg Co, Inc. | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, a |
| 2005-01-07 | Hu-Friedy Mfg Co, Inc. | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, a |
| 2004-03-29 | Hu-Friedy Mfg Co, Inc. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation condu |
| 2004-03-29 | Hu-Friedy Mfg Co, Inc. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation condu |
| 2004-03-29 | Hu-Friedy Mfg Co, Inc. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation condu |
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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.