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

Curette, Periodontic (EMS) (7) Instrument, Hand, Calculus Removal (ELA) (2) Instrument, Ligature Tucking, Orthodontic (ECP) (1)

Premarket Exempt

Yes

Clear

AMERICAN ORTHODONTICS - 00840018600201 Catalog Number :

Device Description : ORTHO ORGANIZERS PLACE/EXPLORER

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600218 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 1-2 "4" HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600225 Catalog Number :

Device Description : CURETTE, HAMMACHER SCGR3-4, STAND HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600232 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 5-6 "4" HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600249 Catalog Number :

Device Description : CURETTE, GRACEY 7-8 HAMMACHER, STD HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600256 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 11-12 "4" HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600263 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 13-14 "4" HNDL

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600270 Catalog Number :

Device Description : CURETTE, HAMMACHER GRACEY 15-16 "4" HND

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : EMS

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600423 Catalog Number :

Device Description : SCALER, HAMMACHER SCN67, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

KARL HAMMACHER GMBH - 00840018600430 Catalog Number :

Device Description : SCALER, HAMMACHER SC204S, "A" HANDLE

Device Class : 1

Duns Number: 053187985

Premarket Exempt : Yes

Product Code : ELA

Prescription Use : No

Device Count : 1

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