Bite Place with 2 Adams Clasps

GUDID 00810126380098

Orthodent Ltd.

Orthodontic palate expander/teeth aligner, self-removable

• Primary Device ID: 00810126380098
• NIH Device Record Key: 30a7dc70-2639-4009-8736-23fb47f5e2b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bite Place with 2 Adams Clasps
• Version Model Number: 0098
• Company DUNS: 251537143
• Company Name: Orthodent Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• 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	00810126380098 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

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: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by Orthodent Ltd.

• 00810126380128 - Bracket Inovation R Positioned: 2024-07-31
• 00810126380135 - Bracket Inovation R: 2024-07-31
• 00810126380005 - Retainer - Soldered: 2024-07-16
• 00810126380012 - Band Loop Space Maintainer: 2024-07-16
• 00810126380029 - Super Spring Speed Aligner: 2024-07-16
• 00810126380036 - Retainer - Soldered - QCM Arch: 2024-07-16
• 00810126380043 - Retainer - Essex: 2024-07-16
• 00810126380050 - Retainer - 6 Acrylic Pads: 2024-07-16