Aligner Treatment Starter Kitz ORN0006-03

GUDID 00850035489079

A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.

Orthonu LLC

Dental restoration/appliance emergency fix kit

• Primary Device ID: 00850035489079
• NIH Device Record Key: 2453aef2-5709-4e9d-9c79-dca0fd8f2f00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aligner Treatment Starter Kitz
• Version Model Number: 0850035489
• Catalog Number: ORN0006-03
• Company DUNS: 125732548
• Company Name: Orthonu LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com
• Phone: 9175965065
• Email: sima@orthonu.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035489079 [Primary]

FDA Product Code

• NYC: Dental Prophylaxis Kit

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 Orthonu LLC

• 00850035489062 - Braces Treatment Starter Kitz: 2025-06-12 A Kit with 5 products including Tweakz for Braces, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
• 00850035489079 - Aligner Treatment Starter Kitz: 2025-06-12A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
• 00850035489079 - Aligner Treatment Starter Kitz: 2025-06-12 A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
• 00850035489031 - Mouth-Aid: 2025-05-05 A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers.
• 00850035489055 - Oral Relief Kitz: 2025-05-05 A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
• 00850035489086 - Comfort Tape: 2025-05-05 A compound intended to be used as a protective cover for the general mucosa to treat irritated gingiva and sensitive teeth.
• 00199284539792 - Comfort Tape™: 2025-03-31 A compound intended to be used as a protective cover for the general mucosa to treat irritated gingiva and sensitive teeth.
• 00199284797581 - Mouth-Aid: 2025-03-31 A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers.
• 00850035489000 - Tweakz for Braces: 2022-09-27