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BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT KIT

G & H Wire Company, Inc. · Model M976K-01 · UDI-DI 10190886000700

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

Description

Full Kit. A unique dual cure composite resin cement ideally suited for cementing metal molar bands. Chemically bonds to both tooth structure and metal band to create a strong anchor. The glass ionomer technology creates high tensile and compressive strength, reducing washout and loose bands. The cement is ideally mixed and has no strong odor or aftertaste. The adhesive can be light cured to immediately set band in place. Without light activation, a complete set is achieved in five minutes. Contains fluoride for added tooth protection. Easily dispensed from economical screw syringes or in smart automix system. Kit contents: 4x 10gm syringes (5gm catalyst & 5gm base), 50 sheet mixing pads, 30 dispensing tips, 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.