DENJOY DENTAL CO.,LTD

DENJOY DENTAL CO.,LTD

Address:F4, A4 Bld, Lugu Medical Device Park,Changsha city Hunan,CN

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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, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment (KIJ) (3) Microscope, Surgical, General & Plastic Surgery (FSO) (3) Plugger, Root Canal, Endodontic (EKR) (2) Instruments, Dental Hand (DZN) (1) Tester, Pulp (EAT) (1)

Premarket Exempt

Yes

Clear

PULP TESTER - 06970873260013 Catalog Number :

Device Class : 2

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : EAT

Prescription Use : Yes

Device Count : 1

Endo Motor - 06970873260051 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : KIJ

Prescription Use : Yes

Device Count : 1

Endo Motor - 06970873260068 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : KIJ

Prescription Use : Yes

Device Count : 1

Endo Motor - 06970873260075 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : KIJ

Prescription Use : Yes

Device Count : 1

Cordless Gutta percha obturation system - 06970873260082 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : EKR

Prescription Use : No

Device Count : 1

Endo Rotary file - 06970873260112 Catalog Number :

Device Description : K file, Machine super file, Machine H file, G file, P file, D root canal dredgin K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill.

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Gutta percha obturation system - 06970873260143 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : EKR

Prescription Use : No

Device Count : 1

Medical Microscope - 06970873260167 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

Medical Microscope - 06970873260174 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

Medical Microscope - 06970873260181 Catalog Number :

Device Class : 1

Duns Number: 529329650

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

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