PDT, Inc.
PDT, INC. · Model R166 Explorer 5 · UDI-DI 00813677021113
3
510(k) clearances
14
Adverse events
7
Recalls
148
Facilities
Description
R166 - The PDT 5 Explorer is one of the most popular explorers for caries detection. Features the 23 Shepherd's Hook Explorer on one end coupled with a 17 Explorer on the other.
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.