Yoshida/Kaycor X-707 Wall Mounted Dental X-Ray

FDA 510(k) K931717 · Kaycor Intl., Ltd.

Substantially Equivalent

510(k) numberK931717

Submission

Device name
Yoshida/Kaycor X-707 Wall Mounted Dental X-Ray
Applicant
Kaycor Intl., Ltd.
Northbrook, IL, US
Received
April 6, 1993
Decision date
September 20, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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K080738Dentron SensorEAP · Traditional Dentron Systems, LLC05/13/2008SE
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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

More from Chicago X-Ray Systems, Inc.

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K965072Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray UnitEHD · Traditional 01/27/1997SE
K832063Robin Cordless HandpieceEKX · Traditional 08/26/1983SE
K822740K30000 Dental ChairKLC · Traditional 09/28/1982SE
K813348Yoshida Rido-F, Model LM-01EKX · Traditional 01/07/1982SE
K811210Yoshida-Panoura 10 · Traditional 08/24/1981SE
K811211Yoshida Ap 100EGY · Traditional 06/16/1981SE

Questions and answers

When was Yoshida/Kaycor X-707 Wall Mounted Dental X-Ray cleared by the FDA?

Yoshida/Kaycor X-707 Wall Mounted Dental X-Ray (K931717) received a 510(k) decision of Substantially Equivalent on September 20, 1993, 167 days after the submission was received.

What is the product code of K931717?

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