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BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT

G & H Wire Company, Inc. · Model M965K-01 · UDI-DI 10190886000649

DYH Prescription
1
510(k) clearances
37
Adverse events (1 deaths)
1
Recalls
66
Facilities

Description

An advanced formula designed as a multipurpose final cement for the cementation of orthodontic bands. The cement is radio-opaque and has cariostatic properties by naturally releasing fluoride. Kit contents: 18gm powder, 17.5ml liquid, 50 sheet mixing pads, measuring scoop, instructions.

Recalls

DateFirmReason
2007-10-31Ormco CorporationMislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

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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.