Minim-X 2001-CIAS & Minim-X 2002-CIAS

FDA 510(k) K882379 · Dentomar, Inc.

Substantially Equivalent

510(k) numberK882379

Submission

Device name
Minim-X 2001-CIAS & Minim-X 2002-CIAS
Applicant
Dentomar, Inc.
Palatine, IL, US
Received
June 9, 1988
Decision date
September 9, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K102573Provu (TM) Dental X-Ray SystemEAP · Traditional Advanced Image Science, Inc.06/30/2011SE
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

Questions and answers

When was Minim-X 2001-CIAS & Minim-X 2002-CIAS cleared by the FDA?

Minim-X 2001-CIAS & Minim-X 2002-CIAS (K882379) received a 510(k) decision of Substantially Equivalent on September 9, 1988, 92 days after the submission was received.

What is the product code of K882379?

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