SmileGoods Right-Bite Aligner Seaters 71098113

GUDID 00723896021927

Plastic seat with three appendages for different areas of arch. Assortment of colors, 24 pack

PRACTICON, INC.

Orthodontic positioner seater

• Primary Device ID: 00723896021927
• NIH Device Record Key: 8d77aec2-7da0-4407-a3fd-bc3ab9331a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmileGoods Right-Bite Aligner Seaters
• Version Model Number: 71098113
• Catalog Number: 71098113
• Company DUNS: 119193803
• Company Name: PRACTICON, INC.
• 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: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00723896021910 [Primary]
GS1	00723896021927 [Package]; Contains: 00723896021910; Package: Case [30 Units]; In Commercial Distribution

FDA Product Code

• ECQ: Aligner, Bracket, 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: 2022-11-15
• Device Publish Date: 2022-11-07

Devices Manufactured by PRACTICON, INC.

• 00723896025994 - SMILEGOODS 3 IN 1 FLOSSERS: 2024-08-15 Flosser that combines a flosser, pick, and interdental brush. Individually wrapped. 500 per pack.
• 00723896026342 - 2.75" X 10" PRACTICON STERILIZATION POUCHES: 2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
• 00723896026373 - 3.5" X 6.5" PRACTICON STERILIZATION POUCHES: 2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
• 00723896026403 - 3.5" X 10" PRACTICON STERILIZATION POUCHES: 2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
• 00723896026434 - 5.25" X 11" PRACTICON STERILIZATION POUCHES: 2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
• 00723896026632 - PRACTIFILM BARRIER FILM BLUE: 2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
• 00723896026663 - PRACTIFILM BARRIER FILM BLACK: 2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
• 00723896026694 - PRACTIFILM BARRIER FILM CLEAR: 2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role