PDT, Inc.
PDT, INC. · Model R169 Explorer ODU 11-12 ER · UDI-DI 00813677021144
3
510(k) clearances
14
Adverse events
7
Recalls
148
Facilities
Description
R169 - The PDT 11-12 Extended Reach Explorer has a tighter radius on the bends, plus an extended terminal shank, that allow for more adaptive, interproximal access for better calculus detection in deeper pockets. ODU stands for Old Dominion University.
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.