Who is Denterprise International, Inc.?

Denterprise International, Inc. (Denterprise), a Florida corporation since 1996, is a specialist with the registration of Medical and Dental Devices and Software with the United States Food and Drug Administration (FDA).

Denterprise’s Resume:

Need FDA Approval On A Dental Device? We Can Help!

Denterprise International, Inc., a Florida corporation since 1996 is a specialist with the registration of Medical and Dental Devices and Software with the United States Food and Drug Administration (FDA).

For information, all invasive devices related to the human body must be registered with the U.S. FDA!

It is a violation to market any such device without a Premarket Notification Approval.

Denterprise International can provide assistance for the registration of your device and file, for you, the 510k Premarket Notification. We can usually obtain clearance within 120 days.

Please find below a partial list of Devices we registered and Companies we consulted with:

Meridian – USA

Universal Radiogrphy – K092543

CEFLA – Italy

Myray Hyperion – K091903

Myray SkyView – K081008

Myray RXDC – K080076

Myray CU-2 – K062897

Myray WDS – K061114

Italia Medica – Italy

UBS / UDD – K080220

Silfradent - Italy

Surgybone K083569

Visiodent – France

RSV – K031448

Ajat – Finland

RetroPan – K051664

Owandy – France

I-Max Touch Pan/Ceph - K083057

Krystal-X WiFi – K070505

I-Max CEPH Digital X-Ray Sensor – K062403

Universal-X (USA) or Krystal-X (Europe) – K053172

Sometech – Korea

X-View – K024186

RF SystemsLab – Japan

Direct Digital Radiography CCD Imaging Sensor NAOMI – K062376

Dentron Systems – USA

Dentron Sensors – K080738

Video Dental Concepts – USA

RetroPan CCD – TWAIN – USB – K070535

OraCam – K020957

MiniCam – K001541

SCDPI - France

Oral Video Scope, OVS - K900541

For further information please contact us at 800-323-2690 or 386-672-0450

Skype with ID: CBerthoin

For further information please contact us at 800-323-2690 or 386-672-0450

 Skype with ID: CBerthoin

Denterprise List of Services

FDA Needs Assessment:

Denterprise will help you determine the classification of your medical device and whether it needs a 510k submission.

Denterprise as your US FDA Agent:

• We act as a liaison between your company and the FDA. We will respond to the FDA’s questions concerning
your products

• We ensure that all regulatory responsibilities and interests of our clients are handled professionally, confidentially
and promptly

• We are a well established FDA US Agent representative doing business with the FDA since 1991!

• We are a US Agent representative for companies in France, Finland, Germany, Italy, Korea and Japan

• We will always look after your interests.

• We have a very reasonable yearly fee for US Agent representation

Denterprise Files 510K:

Denterprise can provide assistance for the registration of your device and file, for you, the 510k Premarket Notification. We can usually obtain clearance within 120 days.

Denterprise’s Fees:

Cost of preparing and submitting a FDA 510k application-many consultants will charge an hourly rate to complete 510k applications, leaving you with the uncertainty of how much it will eventually cost you. Denterprise charges a Fixed Price
to prepare and submit your 510k application to the US Food & Drug Administration. Our price includes unlimited phone and email service during the preparation process of your application.

Our Fixed Price for case review, research, coordinete and obtain data from client, submission perpartion, submission, monitering (tracking), conference with reviewer, answering objections and request additonal information from client, final conference is $7,500 plus. Your actual price is determined by the difficulty of the process – which can be calculated prior to our accepting the work.