SmartArch

GUDID D948SAODREU18251

SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Upper Orthodontic CuNiTi Archwire

Smarter Alloys Inc

Orthodontic archwire

• Primary Device ID: D948SAODREU18251
• NIH Device Record Key: 883492cb-5399-4614-b94a-70a1cedb4a8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartArch
• Version Model Number: SAO-DREU-1825
• 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	D948SAODREU18250 [Primary]
HIBCC	D948SAODREU18251 [Package]; Contains: D948SAODREU18250; 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