SmartByte Palatal Impression Kit

Basic Information

• Brand Name: SmartByte Palatal Impression Kit
• Primary DI: 00860001615319
• Version / Model: SI-004.01
• Company Name: SCIENTIFIC INTAKE LIMITED CO.
• Labeler DUNS: 827444881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-23
• Public Version: 1
• Public Version Date: 2019-05-31
• Public Version Status: New
• Public Device Record Key: f0d25913-6c63-4fe0-8302-a18ed28104b4

Device Description

Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower teeth

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
48085	Dental impression material kit, single-use	A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001615319	GS1