SureSmile attachment template

GUDID 00856379007030

ORAMETRIX, INC.

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• Primary Device ID: 00856379007030
• NIH Device Record Key: bc69c110-9dea-42bb-8f3d-07b7b957ad6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSmile attachment 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	00856379007030 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [SureSmile attachment template]

• 00856379007030: 2000
• 00856379007047: 3000