SmartArch

GUDID D948SAODROL00161

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

Smarter Alloys Inc

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire

• Primary Device ID: D948SAODROL00161
• NIH Device Record Key: f254a972-e967-46df-b9d3-6971139ac031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartArch
• Version Model Number: SAO-DROL-0016
• Company DUNS: 200106716
• Company Name: Smarter Alloys Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D948SAODROL00160 [Primary]
HIBCC	D948SAODROL00161 [Package]; Contains: D948SAODROL00160; Package: Envelope [10 Units]; In Commercial Distribution

FDA Product Code

• DZC: Wire, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

On-Brand Devices [SmartArch]

• D948SAODROU00160: SmartArch .016" (0.406mm) Round Damon Upper Orthodontic CuNiTi Archwire
• D948SAODROL00161: SmartArch .016" (0.406mm) Round Damon Lower Orthodontic CuNiTi Archwire
• D948SAODREU18251: SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Upper Orthodontic CuNiTi Archwire
• D948SAODREL18251: SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Lower Orthodontic CuNiTi Archwire