SmartArch

Basic Information

• Brand Name: SmartArch
• Primary DI: D948SAODROU00160
• Version / Model: SAO-DROU-0016
• Company Name: Smarter Alloys Inc
• Labeler DUNS: 200106716
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-05
• Public Version: 1
• Public Version Date: 2021-04-13
• Public Version Status: New
• Public Device Record Key: d65641d4-9b50-402f-a5d5-d21129d9a958

Device Description

SmartArch .016" (0.406mm) Round Damon Upper Orthodontic CuNiTi Archwire

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: No
• 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
DZC	Wire, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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	D948SAODROU00160	HIBCC
Package	D948SAODROU00161	HIBCC	Envelope	10	In Commercial Distribution