sureclear aligner

GUDID 00856379007009

ORAMETRIX, INC.

Orthodontic appliance system, progressive

• Primary Device ID: 00856379007009
• NIH Device Record Key: 3af726e4-730a-4c22-bb7e-d773e9fffb08
• Commercial Distribution Discontinuation: 2019-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: sureclear aligner
• Version Model Number: 1000
• 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	00856379007009 [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