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PDT, Inc.

PDT, INC. · Model R972 RDH Exam Kit · UDI-DI 00813677024404

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10
510(k) clearances
47
Adverse events
1
Recalls
371
Facilities

Description

Kit Includes: T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R245 Mirror Handle (Cone-Socket) R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R166 Explorer 5 T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5

Recalls

DateFirmReason
2021-03-23Sunstar Americas, Inc.Product may be contaminated with Burkholderia contaminans.

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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.