NORDENT MANUFACTURING INC

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

Spreader, Pulp Canal Filling Material, Endodontic (EKK) (8) Carver, Wax, Dental (EIK) (1) Instrument, Hand, Calculus Removal (ELA) (1)

Premarket Exempt

Yes

Clear

BRASSELER USA - 00840018600003 Catalog Number :

Device Description : BRAS 25ONDTD11T NITI D11T 21MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600010 Catalog Number :

Device Description : NTD11T25 NITI D11T 25MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600027 Catalog Number :

Device Description : NT4SP NITI SPREADER 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600034 Catalog Number :

Device Description : NTD11T4 NITI D11T 21MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600041 Catalog Number :

Device Description : NT4SP4 NITI SPREADER 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600058 Catalog Number :

Device Description : NTD11T216 NITI D11T 21MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600065 Catalog Number :

Device Description : NTD11T256 NITI D11T 25MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600072 Catalog Number :

Device Description : NTMA57286 NITI ENDO 28MM 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : No

Device Count : 1

BRASSELER USA - 00840018600089 Catalog Number :

Device Description : WAX31 WAX INSTRUMENT 1P

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EIK

Prescription Use : No

Device Count : 1

AMERICAN ORTHODONTICS - 00840018600096 Catalog Number :

Device Description : AO SCALER SPECIAL U15/CI1

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

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