CEFLA SOCIETA' COOPERATIVA

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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) (5) System,X-Ray,Extraoral Source,Digital (MUH) (4) X-Ray, Tomography, Computed, Dental (OAS) (3) Controller, Foot, Handpiece And Cord (EBW) (1)

Premarket Exempt

Yes No

Clear

Castellini - 08033837931799 Catalog Number : 706S0061

Device Description : CASTELLINI RX DC - REF: CAEU174CM

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931805 Catalog Number : 706N0010

Device Description : NEWTOM RX DC - REF: NMPU174WS

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931812 Catalog Number : 706N0011

Device Description : NEWTOM RX DC - REF: NMPU174CS

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931829 Catalog Number : 706N0060

Device Description : NEWTOM RX DC - REF: NMPU174WM

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931836 Catalog Number : 706N0061

Device Description : NEWTOM RX DC - REF: NMPU174CM

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931850 Catalog Number : XSENSONEWTOM

Device Description : The X-VS sensor is intended to capture intraoral digital images when exposed to X-Rays.

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

myray - 08033837931881 Catalog Number : 70A10000

Device Description : Digital panoramic, cephalometric and tomographic extra-oral X-ray system.

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

NewTom - 08033837931898 Catalog Number : 70A30000

Device Description : Digital panoramic, cephalometric and tomographic extra-oral X-ray system.

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

Castellini - 08033837931904 Catalog Number : 70A50000

Device Description : Digital panoramic, cephalometric and tomographic extra-oral X-ray system.

Device Class : 2

Duns Number: 429341410

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

Castellini - 08033837932789 Catalog Number : 95520433

Device Description : The CEFLA Dental Micromotors are brushless electric micromotors controlled by a The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed.They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.

Device Class : 1

Duns Number: 429341410

Premarket Exempt : No

Product Code : EBW

Prescription Use : Yes

Device Count : 1

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