Access Dental Lab, LLC

Access Dental Lab, LLC

Address:1530 Antioch Pike,Antioch,TN,37013,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Toothbrush, Powered (JEQ) (5) Aligner, Sequential (NXC) (4) Positioner, Tooth, Preformed (KMY) (1)

Premarket Exempt

No Yes

Clear

sequential aligner - 00850007728007 Catalog Number :

Device Description : sequential aligner system

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MIDCOURSE CORRECTIONS KIT - 00850007728014 Catalog Number :

Device Description : MIDCOURSE CORRECTIONS KIT

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

REFINEMENT CORRECTION KIT - 00850007728021 Catalog Number :

Device Description : REFINEMENT CORRECTION KIT

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

RETAINER KIT - 00850007728038 Catalog Number :

Device Description : RETAINER KIT

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : KMY

Prescription Use : Yes

Device Count : 1

REPLACEMENT ALIGNERS - 00850007728045 Catalog Number :

Device Description : REPLACEMENT ALIGNERS

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

electric toothbrush - 00850007728052 Catalog Number :

Device Description : powered toothbrush-Power toothbrush-Blurple-retail

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Electric Toothbrush - 00850007728069 Catalog Number :

Device Description : Power toothbrush-Blurple-ECOMM

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

ElectricToothbrush - 00850007728076 Catalog Number :

Device Description : Powered tooth brush gunmetal-Retail

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Electric Toothbrsuh - 00850007728083 Catalog Number :

Device Description : Power toothbrush-Gunmetal-ECOMM

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

electric toohbrush - 00850007728090 Catalog Number :

Device Description : Powered toothbrush-Replacement TOOTHBRUSH Head

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

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