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

Aligner, Sequential (NXC) (4) Cleaner, Ultrasonic, Medical Instrument (FLG) (1) Toothbrush, Powered (JEQ) (1) Unit, Oral Irrigation (EFS) (1)

Premarket Exempt

Yes No

Clear

ACCESS DENTAL LAB - 00850007728113 Catalog Number :

Device Description : NIGHTTIME CLEAR ALIGNERS-SEQUENTIAL ALIGNERS

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

ACCESS DENTAL LAB - 00850007728120 Catalog Number :

Device Description : NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

ACCESS DENTAL LAB - 00850007728137 Catalog Number :

Device Description : NIGHTTIME CLEAR ALIGNER - REFINEMENT CORRECTIONS

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

ACCESS DENTAL LAB - 00850007728144 Catalog Number :

Device Description : NIGHTTIME CLEAR ALIGNER REPLACEMENT ALIGNERS

Device Class : 2

Duns Number: 054012763

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Smile Spa - 00850007728151 Catalog Number :

Device Description : Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, alig Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more.

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Water Flosser - 00850007728168 Catalog Number :

Device Description : Water Flosser removes 99% of the plaque between teeth and below the gumline

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 1

Access Dental Lab - 00850007728182 Catalog Number :

Device Description : Power toothbrush replacement head refill 2 pack

Device Class : 1

Duns Number: 054012763

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

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