SMILEGOODS ALIGNER CHEWIES MINT 71098134 MIN

GUDID 00723896026878

Silicone tube used to help seat a clear aligner by biting down on the device. 120 per pack

PRACTICON, INC.

Orthodontic aligner/retainer seater, single-use
Primary Device ID00723896026878
NIH Device Record Keyacaf768f-b47a-4868-8412-1614b7373707
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMILEGOODS ALIGNER CHEWIES MINT
Version Model Number71098134 MIN
Catalog Number71098134 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
GS100723896026878 [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.

00723896025994 - SMILEGOODS 3 IN 1 FLOSSERS2024-08-15 Flosser that combines a flosser, pick, and interdental brush. Individually wrapped. 500 per pack.
00723896026342 - 2.75" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026373 - 3.5" X 6.5" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026403 - 3.5" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026434 - 5.25" X 11" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026632 - PRACTIFILM BARRIER FILM BLUE2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026663 - PRACTIFILM BARRIER FILM BLACK2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026694 - PRACTIFILM BARRIER FILM CLEAR2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role

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