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

Unit, X-Ray, Extraoral With Timer (EHD) (4) X-Ray, Tomography, Computed, Dental (OAS) (3) Scaler, Ultrasonic (ELC) (2) Handpiece, Air-Powered, Dental (EFB) (1)

Premarket Exempt

No Yes

Clear

T3 mini - E27659501130 Catalog Number :

Device Description : T3 mini Borden

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

SIROPERIO - E27659502460 Catalog Number :

Device Description : SIROPERIO-SETconsists of:E27660448900 SIROPERIO 1 internalE27660449080 SIROPERIO SIROPERIO-SETconsists of:E27660448900 SIROPERIO 1 internalE27660449080 SIROPERIO 2 internalE27660449160 SIROPERIO 3 internal

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659502530 Catalog Number :

Device Description : SIROPREP - SETconsists of:E27659028820 SIROPREP M 1, unpackedE27659028900 SIROPR SIROPREP - SETconsists of:E27659028820 SIROPREP M 1, unpackedE27659028900 SIROPREP D 1, unpackedE27659473250 SIROPREP M 2, unpackedE27659473330 SIROPREP D 2, unpacked

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

ORTHOPHOS XG - E27659638500 Catalog Number :

Device Description : ORTHOPHOS XG 3D ready

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

ORTHOPHOS XG - E27659638680 Catalog Number :

Device Description : ORTHOPHOS XG 3D ready Ceph

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Sleeve for extraoral X-Ray devices - E27659682552 Catalog Number :

Device Description : Hygienic protective for handle

Device Class :

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 100

Sleeve for extraoral X-Ray devices - E27659682632 Catalog Number :

Device Description : Hygienic protective for forehead

Device Class :

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 500

ORTHOPHOS XG - E27659933860 Catalog Number :

Device Description : ORTHOPHOS XG 5 Ceph/XG 5DS Ceph

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

ORTHOPHOS XG - E27659933940 Catalog Number :

Device Description : ORTHOPHOS XG 5 / XG 5DS

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

ORTHOPHOS XG - E27659934020 Catalog Number :

Device Description : Cephalometer retrofit left / right

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

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