Splintastik

Basic Information

• Brand Name: Splintastik
• Primary DI: 00842092110737
• Version / Model: 0200001
• Catalog Number: 0200001
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-17
• Public Version: 2
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 04170ab0-5c3e-4cc0-a95a-43e1831c23f7

Device Description

Splintastik Starter Kit

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63662	Dental implant suprastructure reamer	A manually-operated dental laboratory instrument intended to be used to smooth and refine the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, by means of a rotating abrasive action. It is used to remove minor casting flashes on the mating surface of the suprastructure during the production of a final suprastructure; it is not intended for intraoral use. It is in the form of a metallic cylinder which may be cannulated, and is available in various diameters and sizes. This is a reusable device.	No	Active
35170	Dental mandrel	A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.	No	Active
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842092110737	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]