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SKY CHOICE

Hexa Dental · Model KY1305 · UDI-DI 00850023750495

EHK Prescription
8
510(k) clearances
3
Adverse events
1
Recalls
121
Facilities

Description

Sky Choice Prophy Paste Splatter - Free Containing 1.23% Fluoride ( Coarse) Assorted 200/Box

Recalls

DateFirmReason
2023-07-20Cosmedent, Inc.Reports were received the elastomer cup material is crumbling.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.