sureclear template

GUDID 00856379007016

ORAMETRIX, INC.

Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• Primary Device ID: 00856379007016
• NIH Device Record Key: 960fb2b4-6b7d-4bbc-a8c5-7be8bd97523a
• Commercial Distribution Discontinuation: 2019-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: sureclear template
• Version Model Number: 2000
• Company DUNS: 053101262
• Company Name: ORAMETRIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00856379007016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171860

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-24
• Device Publish Date: 2018-03-05

Devices Manufactured by ORAMETRIX, INC.

• 00856379007283 - Motto: 2023-03-16 Motto Aligner
• 00856379007290 - Motto: 2023-03-16 Motto Attachment Template
• 00856379007306 - Motto: 2023-03-16 Motto Retainer
• 00856379007122 - SureSmile®: 2022-05-17 Arch wire 16round CUNITI-NITI
• 00856379007139 - SureSmile®: 2022-05-17 Arch wire 16x22 CUNITI-NITI
• 00856379007146 - SureSmile®: 2022-05-17 Arch wire 17x25 CUNITI-NITI
• 00856379007153 - SureSmile®: 2022-05-17 Arch wire 19x25 CUNITI-NITI
• 00856379007160 - SureSmile®: 2022-05-17 Arch wire 17x25 ELGILOY