amda®

Basic Information

• Brand Name: amda®
• Primary DI: J011607185010
• Version / Model: 607-185-01
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 6
• Public Version Date: 2022-12-22
• Public Version Status: Update
• Public Device Record Key: 9df06f81-3c95-43be-9dad-7e7de1e0028e

Device Description

amda® palatal arch

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: 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
DYJ	RETAINER, SCREW EXPANSION, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64769	Orthodontic palate expander/teeth aligner, bonded	An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavity with wires extending laterally, ending in bonded teeth-engaging bands. It is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J011607185010	HIBCC

Customer Contacts

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

Storage Conditions

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