DENTERPRISE INTERNATIONAL, INC.

Address:156 E Granada Blvd,Ormond Beach,FL,32176,US

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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

System, X-Ray, Extraoral Source, Digital (MUH) (2) Syringe, Cartridge (EJI) (1) Unit, X-Ray, Extraoral With Timer (EHD) (1)

Premarket Exempt

No Yes

Clear

EZ-Flow - 00858475006139 Catalog Number :

Device Description : The EZ-Flow Anesthetic Delivery System is a device used for the injection of loc The EZ-Flow Anesthetic Delivery System is a device used for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with,dental procedures.

Device Class : 2

Duns Number: 024913248

Premarket Exempt : Yes

Product Code : EJI

Prescription Use : Yes

Device Count : 1

Acuflow - 00858475006146 Catalog Number :

Device Description : The Acuflow Anesthetic Delivery System is a device used for injection of local a The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure.

Device Class :

Duns Number: 024913248

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

MOBILE-X - 00858475006153 Catalog Number :

Device Description : The device is a diagnostic X-ray system, which is intended to be used by trained The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental X-ray source for producing diagnostic X-ray images using intra-oral image receptors Its use is in adults and pediatric subjects.

Device Class : 2

Duns Number: 024913248

Premarket Exempt : Yes

Product Code : EHD

Prescription Use : No

Device Count : 1

InstaRay - 00858475006177 Catalog Number : 02HAM15102

Device Class : 2

Duns Number: 024913248

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

InstaRay - 00858475006184 Catalog Number : 02HAM15302

Device Description : Indications for Use: Radiographic examination and diagnosis of diseases of the Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

Device Class : 2

Duns Number: 024913248

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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