NORDENT MANUFACTURING INC

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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

Instrument, Ligature Tucking, Orthodontic (ECP) (5) Condenser, Amalgam And Foil, Operative (EKG) (1) Explorer, Operative (EKB) (1) Handle, Instrument, Dental (EJB) (1) Pusher, Band, Orthodontic (ECS) (1) Setter, Band, Orthodontic (ECR) (1)

Premarket Exempt

Yes

Clear

AMERICAN ORTHODONTICS - 00840018600102 Catalog Number :

Device Description : AO WIRE TWISTER SMALL SIZE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600119 Catalog Number :

Device Description : AO DISTAL TWISTER .021 X .025

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600126 Catalog Number :

Device Description : AO SE EXPLORER 23

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600133 Catalog Number :

Device Description : AO MIRROR HANDLE M10

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600140 Catalog Number :

Device Description : AO CONDENSER BLK7/SPECIAL CN

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKG

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600157 Catalog Number :

Device Description : AO TYME SHUTTER TOOL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600164 Catalog Number :

Device Description : AO TYME SHUTTER TOOL SHORT HNDL.

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600171 Catalog Number :

Device Description : AO USA BAND SEATER N114, DL HEX HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECR

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600188 Catalog Number :

Device Description : AO USA FE/LD EXPLORER/LIG. DIRECTOR

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600195 Catalog Number :

Device Description : AO BAND PLUGGER / CEMENT SCALER

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECS

Prescription Use : No

Device Count : 1

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