ELATION® MB

Basic Information

• Brand Name: ELATION® MB
• Primary DI: D807133111601
• Version / Model: 133-111-60
• Catalog Number: 133-111-60
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 4
• Public Version Date: 2021-01-18
• Public Version Status: Update
• Public Device Record Key: 0d702b88-8cac-47e1-b279-f4539c907aa7
• Distribution End Date: 2021-01-15

Device Description

ELATION® MB Base Rx 018/UR1 12T 5A

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYW	BRACKET, PLASTIC, ORTHODONTIC	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46582	Orthodontic bracket, plastic, single-use	A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be 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	D807133111601	HIBCC
Unit of Use	D807133111600	HIBCC

Customer Contacts

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