Denterprise - Denterprise

Obtaining FDA medical device clearance requires experience and professional guidance throughout the entire process.  At 510kFDA, we are your trusted adviser and always act as your liaison and advocate with the FDA.  

We start with a thorough analysis of your product to better manage the entire process.  We find the best initial predicate device, product code, and registration number through FDA to match your entry; and then address all requirements from the FDA so your device meets the necessary guidelines and specifications for clearance unique to your product.  We stay connected through the process to insure all ISO testing is handled accordingly and your product meets the important safety requirements under FDA guidelines.  We prepare and diligently manage all documentation and  facilitate the entire electronic submission & coordinate filing fees or potential 3rd party ISO related costs.  We work diligently to update you with accurate and concise data around the process, so you can continue to make informed decisions. 





Str. Cassia Nord Km 86,300
01100 Viterbo - Italy
T +39 0761 352198
F +39 0761 352133
VAT: IT01612570562


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