Clear Express Aligners

GUDID 00860013140717

Partial sequential aligners

Ohlendorf Co.

Orthodontic progressive aligner

• Primary Device ID: 00860013140717
• NIH Device Record Key: cdf7fd21-77fb-4595-adf3-4aac33d72f11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Express Aligners
• Version Model Number: EXP102
• Company DUNS: 119495073
• Company Name: Ohlendorf Co.
• 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: 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
GS1	00860013140717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210540

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: 2025-06-12
• Device Publish Date: 2025-06-04

Devices Manufactured by Ohlendorf Co.

• 00860013140700 - Clear Force Aligners: 2025-06-12 Full arch sequential aligners
• 00860013140717 - Clear Express Aligners: 2025-06-12Partial sequential aligners
• 00860013140717 - Clear Express Aligners: 2025-06-12 Partial sequential aligners