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

Scaler, Ultrasonic (ELC) (8) Handpiece, Air-Powered, Dental (EFB) (1) X-Ray, Tomography, Computed, Dental (OAS) (1)

Premarket Exempt

No Yes

Clear

SIRORETRO - E27659250240 Catalog Number :

Device Description : SIRORETRO KR PROD

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIRORETRO - E27659250320 Catalog Number :

Device Description : SIRORETRO GL PROD

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIRORETRO - E27659250400 Catalog Number :

Device Description : SIRORETRO GR PROD

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Sleeve for extraoral X-Ray devices - E27659326032 Catalog Number :

Device Description : Hygienic protective for chin rest a. bar

Device Class :

Duns Number: 340306351

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 100

T3 Racer - E27659372680 Catalog Number :

Device Description : T3 Racer Midwest

Device Class : 1

Duns Number: 340306351

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659473090 Catalog Number :

Device Description : SIROPREP D1

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659473250 Catalog Number :

Device Description : SIROPREP M 2, unpacked

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659473330 Catalog Number :

Device Description : SIROPREP D 2, unpacked

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659473580 Catalog Number :

Device Description : SIROPREP M 2

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

SIROPREP - E27659473660 Catalog Number :

Device Description : SIROPREP D 2

Device Class : 2

Duns Number: 340306351

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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