tomas®

Basic Information

• Brand Name: tomas®
• Primary DI: J011302208300
• Version / Model: 302-208-30
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 1123a3c1-08a0-4ee2-b8ff-ce09b258d1cf

Device Description

tomas® anchorage system: tomas®-pin EP N 08 (unsterile)/ Length 8 mm/ sterilizable/ Core ø 1.2 mm/ For further information please visit our online-shop on www.dentaurum.de

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAT	Implant, endosseous, orthodontic	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46536	Orthodontic anchoring screw	A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J011302208300	HIBCC
Unit of Use	J011302208301	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required