FDA.reportPublic FDA data

SMILEGOODS ALIGNER CHEWIES MINT

Primary DI
00723896026878
Brand
SMILEGOODS ALIGNER CHEWIES MINT
Company
PRACTICON, INC.
Model
71098134 MIN
Catalog number
71098134 MIN
Device description
Silicone tube used to help seat a clear aligner by biting down on the device. 120 per pack
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723896026878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896026878007238960268787238960268780723896026878

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, single-useA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119193803
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029879Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029909Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030288ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030318ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030349ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030370ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030400ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030431ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030462ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030493ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030523ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030554ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030585ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
00723896029855Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08

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Primary DI, Brand, Company table
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