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P.P. BlueShaper Z3

NUSMILE, LTD. · Model PP-144 · UDI-DI 00810092939092

EKN
7
510(k) clearances
0
Adverse events
5
Recalls
86
Facilities

Description

100 units

Recalls

DateFirmReason
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

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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.