Provu (TM) Dental X-Ray System

FDA 510(k) K102573 · Advanced Image Science, Inc.

Substantially Equivalent

510(k) numberK102573

Submission

Device name
Provu (TM) Dental X-Ray System
Applicant
Advanced Image Science, Inc.
Campbell, CA, US
Received
September 9, 2010
Decision date
June 30, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EAP – Unit, X-Ray, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1810
Specialty
Dental

Other 510(k)s with product code EAP

510(k)DeviceApplicantDecision
K113360Medical Image Processing UnitEAP · Special Humanray Co,Ltd02/07/2012SE
K093453Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.11/30/2009SE
K080738Dentron SensorEAP · Traditional Dentron Systems, LLC05/13/2008SE
K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special Flow X-Ray Corp.09/27/2005SE
K041385Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.06/07/2004SE
K960819Heliodent DSEAP · Traditional Pelton & Crane Co.03/29/1996SE
K960028Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional Dentsply Intl.03/01/1996SE
K953936AtlantisEAP · Traditional Trophy Radiologie12/28/1995SE
K954565Explor-X (Azteh) HFEAP · Traditional Chicago X-Ray Systems, Inc.10/27/1995SE
K951734Lumix 70BEAP · Traditional Emix U.S.A., Inc.07/20/1995SE

Questions and answers

When was Provu (TM) Dental X-Ray System cleared by the FDA?

Provu (TM) Dental X-Ray System (K102573) received a 510(k) decision of Substantially Equivalent on June 30, 2011, 294 days after the submission was received.

What is the product code of K102573?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.