DENTIS CO. ,LTD

Address:99, Seongseoseo-ro, Dalseo-Gu,Daegu,KR

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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

Accessories, Implant, Dental, Endosseous (NDP) (10)

Premarket Exempt

No Yes

Clear

Guide Wheel Guide Pole - 08800053004688 Catalog Number :

Device Description : Dental Implant Instrument / Guide Wheel Guide Pole

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Simple Guide Plus Sleeve Connector - 08800053004701 Catalog Number :

Device Description : Dental Implant Instrument / Simple Guide Plus Sleeve Connector

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Expander drill - 08800053004923 Catalog Number :

Device Description : Dental Implant Instrument / Expander drill

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Expander drill - 08800053004930 Catalog Number :

Device Description : Dental Implant Instrument / Expander drill

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Expander drill - 08800053004947 Catalog Number :

Device Description : Dental Implant Instrument / Expander drill

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Expander drill - 08800053004954 Catalog Number :

Device Description : Dental Implant Instrument / Expander drill

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Expander drill - 08800053004961 Catalog Number :

Device Description : Dental Implant Instrument / Expander drill

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Spreading pin - 08800053004978 Catalog Number :

Device Description : Dental Implant Instrument / Spreading pin

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Wrench - 08800053004985 Catalog Number :

Device Description : Dental Implant Instrument / Wrench

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Handpiece condenser - 08800053004992 Catalog Number :

Device Description : Dental Implant Instrument / Handpiece condenser

Device Class : 1

Duns Number: 694721181

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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