Preat Implant Prosthetics

Basic Information

• Brand Name: Preat Implant Prosthetics
• Primary DI: 00842092178690
• Version / Model: 9000703
• Catalog Number: 9000703
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-09
• Public Version: 2
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 6862244e-f1f6-4a5a-b5d0-b448272c8ac9

Device Description

Nobel Tri-Lobe 6.0mm Digital Analog Kit contains: 1 Nobel Tri-Lobe 6.0mm Digital Analog 1 Digital Analog Base Screw

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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842092178706	GS1	Pack	10	In Commercial Distribution
Primary	00842092178690	GS1
Package	00842092178713	GS1	Pack	25	In Commercial Distribution

Customer Contacts

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