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 ID00723896021927
NIH Device Record Key8d77aec2-7da0-4407-a3fd-bc3ab9331a9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileGoods Right-Bite Aligner Seaters
Version Model Number71098113
Catalog Number71098113
Company DUNS119193803
Company NamePRACTICON, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100723896021910 [Primary]
GS100723896021927 [Package]
Contains: 00723896021910
Package: Case [30 Units]
In Commercial Distribution

FDA Product Code

ECQAligner, Bracket, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-15
Device Publish Date2022-11-07

Devices Manufactured by PRACTICON, INC.

00723896029855 - Practicon Color Splash™ Saliva Ejectors 100/Pack2026-01-16 Saliva ejector used to clear water from the mouth during dental procedures. Assorted green, pink, purple, and blue opaque vinyl.
00723896029886 - Practicon Bliss™ Level 3 Face Mask 50/Box Black2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
00723896029916 - Practicon Bliss™ Level 3 Face Mask 50/Box Blue2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
00723896030295 - ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
00723896030325 - ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
00723896030356 - ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
00723896030387 - ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
00723896030417 - ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag

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