Implant Prosthetics

Basic Information

• Brand Name: Implant Prosthetics
• Primary DI: 20842092102811
• Version / Model: 8003250-10
• Catalog Number: 8003250-10
• Company Name: Preat Corporation
• Labeler DUNS: 117776048
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 8
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: cbfd12d5-3735-4e3d-9b3a-9a94a6ddfba2
• Distribution End Date: 2023-08-09

Device Description

CAMLOG® Screw-Line-compatible 3.3/3.8/4.3 Titanium Implant Screw (10-Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20842092102811	GS1

Customer Contacts

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