Seamfree Kit - Wetting Resin (3ml Bottle)

Basic Information

• Brand Name: Seamfree Kit - Wetting Resin (3ml Bottle)
• Primary DI: 00850194007329
• Version / Model: 1
• Catalog Number: 104-02
• Company Name: Vista Dental
• Labeler DUNS: 036623932
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 4
• Public Version Date: 2021-02-04
• Public Version Status: Update
• Public Device Record Key: 450c117a-4da6-47a5-897e-61d76fc75df7

Device Description

Seamfree Kit - Wetting Resin (3ml Bottle)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47916	Dental restorative unfilled resin kit, standard	A collection of standard equipment and supplies intended to be used to fill dental cavities or restore damaged dental tissue with unfilled resin, such as polymethylmethacrylate (PMMA), that does not contain or contains very small amounts of inert filler materials. It typically includes dental cannulae (tips), finishing discs, polishing paste, polishing cups, and a tips gun. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850194007329	GS1

Premarket Submissions

Submission Number	Supplement Number
K092539	000