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510(k) Data Aggregation
K Number
K073209Device Name
MAXCEM 2
Manufacturer
KERR CORPORATION
Date Cleared
2008-01-29
(76 days)
Product Code
MZW, EMA
Regulation Number
872.3275Why did this record match?
Product Code :
MZW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants. * Adhesive application on the prep is required for veneer cementation using Maxcem 2.
Device Description
Maxcem 2 is a self-etch, self-adhesive resin cement offered in a paste/paste formulation indicated for indirect cementation of ceramic, resin and metal restorations including veneers. This product contains 69% filler by weight and is radiopaque. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration or tooth prep.
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K Number
K991923Device Name
SOOTHE-N-SEAL CANKER SORE RELIEF
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
1999-09-02
(87 days)
Product Code
MZW
Regulation Number
872.3275Why did this record match?
Product Code :
MZW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.
Device Description
SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application.
SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life.
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