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Sklar®

SKLAR CORPORATION · Model 49-0660 · UDI-DI 10649111170072

EKB
3
510(k) clearances
14
Adverse events
7
Recalls
148
Facilities

Description

EXPLORER RND HANDL DE #5

Recalls

DateFirmReason
2005-01-07Hu-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
2005-01-07Hu-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
2005-01-07Hu-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
2005-01-07Hu-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
2004-03-29Hu-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
2004-03-29Hu-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
2004-03-29Hu-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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Data 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.