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PDT, INC. · Model R933 PDT Cement (Crown Seating) Kit · UDI-DI 00813677024947

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

Description

Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R375) Mixing Spatula-Applicator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium

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.