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, Hand, Calculus Removal (ELA) (9) Curette, Periodontic (EMS) (1)

Premarket Exempt

Yes

Clear

KARL HAMMACHER GMBH - 00840018600447 Catalog Number :

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600454 Catalog Number :

Device Description : SCALER, HAMMACHER SCJ2S-3S, "A" HAMDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600461 Catalog Number :

Device Description : SCALER, HANNACHER SC204SD "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600478 Catalog Number :

Device Description : SCALER, HAMMACHER SCCUMINE, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600485 Catalog Number :

Device Description : SCALER, HAMMACHER SCCO2R-2L, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600492 Catalog Number :

Device Description : SCALER, HAMMACHER SCCO4R-4L, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600508 Catalog Number :

Device Description : SCALER, HAMMACHER SCM17-18, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600515 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 1-2, "A" HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600522 Catalog Number :

Device Description : SCALER, HAMMACHER SCGR3-4, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600539 Catalog Number :

Device Description : SCALER, HAMMACHER SCGR5-6, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

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