SMILEGOODS ALIGNER CHEWIES MINT 24 PACK 71098133 MIN

GUDID 00723896026847

Silicone tube used to help seat a clear aligner by biting down on the device. 24 per pack

PRACTICON, INC.

Orthodontic aligner/retainer seater, single-use
Primary Device ID00723896026847
NIH Device Record Key0133cec4-5d10-46b6-aed3-f18647b928ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMILEGOODS ALIGNER CHEWIES MINT 24 PACK
Version Model Number71098133 MIN
Catalog Number71098133 MIN
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100723896026847 [Primary]

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 Date2024-08-15
Device Publish Date2024-08-07

Devices Manufactured by PRACTICON, INC.

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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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