SIRONA Dental Systems GmbH

Address:FABRIKSTRASSE 31,Bensheim Hesse,DE

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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

Handpiece, Air-Powered, Dental (EFB) (3) Scaler, Ultrasonic (ELC) (3) X-Ray, Tomography, Computed, Dental (OAS) (2) Abutment, Implant, Dental, Endosseous (NHA) (1) Dental Abutment Design Software For Dental Laboratory (PNP) (1) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (1)

Premarket Exempt

No Yes

Clear

CAD/CAM Software - E26767323610 Catalog Number :

Device Description : CEREC Software Version 5.1.0 Licence

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : NHA, PNP

Prescription Use : Yes

Device Count : 1

T1 Spray - E27618942990 Catalog Number :

Device Description : T1 Spray (50ML) VOC 21,77g

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

SIROSONIC Instrument - E27618943070 Catalog Number :

Device Description : CEM-Set No.6L

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROSONIC Instrument - E27618944550 Catalog Number :

Device Description : INSTRUMENT No. 3L

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROSONIC Instrument - E27618944630 Catalog Number :

Device Description : INSTRUMENT No.4L

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Quick coupling - E27618945880 Catalog Number :

Device Description : Quick coupling R

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

T1 LINE - E27618947370 Catalog Number :

Device Description : T1 LINE CONDENS

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

T1 LINE - E27618949010 Catalog Number :

Device Description : T1 LINE PROPHY

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

Sleeve for extraoral X-Ray devices - E27633140722 Catalog Number :

Device Description : Hygienic protective sleeve f. bite block

Device Class :

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 500

Sleeve for extraoral X-Ray devices - E27633140802 Catalog Number :

Device Description : Hygienic protective sleeve f. bite block

Device Class :

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 500

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