Preat Implant Prosthetics

Basic Information

• Brand Name: Preat Implant Prosthetics
• Primary DI: 00842092156919
• Version / Model: 8000090
• Catalog Number: 8000090
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 3
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 46138587-485a-4071-97d7-7907840396fd
• Distribution End Date: 2023-11-30

Device Description

Blue Light ScanBuddy 1 (10-Pack) Kit includes: Zimmer TSV 3.5mm Blue Light Lab Scan Body Straumann® BL-compatible NC Blue Light Scan Body NobelActive™/Conical-compatible RP Blue Light Scan Body NobelActive™/Conical-compatible NP Blue Light Scan Body Hiossen® HG-compatible Standard Blue Light Scan Body MegaGen AnyRidge®-compatible Blue Light Scan Body Zimmer® TSV-compatible 4.5mm Blue Light Lab Scan Body NobelActive™/Conical-compatible WP Blue Light Scan Body Straumann® BL-compatible RC Blue Light Scan Body Multi-Unit Scan Body - .050

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
61641	Dental implant abutment analog, scanning	A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842092156919	GS1

Customer Contacts

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