tomas®

Basic Information

• Brand Name: tomas®
• Primary DI: J011302602000
• Version / Model: 302-602-00
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-10-30
• Public Version: 4
• Public Version Date: 2025-12-04
• Public Version Status: Update
• Public Device Record Key: 64df24d6-e5e2-4d62-812c-95e199080e84

Device Description

tomas® RPE eyelet / coupling element for RPE screws between tomas®-pin with hyrax® or hyrax® click

Device Characteristics

• Single Use: No
• 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: Yes
• 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: No

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
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J011302602000	HIBCC
Unit of Use	J011302602001	HIBCC

Customer Contacts

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

Storage Conditions

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