Yoshida Ap 100

FDA 510(k) K811211 · Kaycor Intl., Ltd.

Substantially Equivalent

510(k) numberK811211

Submission

Device name
Yoshida Ap 100
Applicant
Kaycor Intl., Ltd.
Mchenry, IL, US
Received
May 4, 1981
Decision date
June 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EGY – Processor, Radiographic-Film, Automatic, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1900
Specialty
Radiology

Other 510(k)s with product code EGY

510(k)DeviceApplicantDecision
K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)EGY · Traditional Dental X-Ray Support Systems, Inc.09/03/1999SE
K955825Smith S-100 Time & Temperature ControlEGY · Traditional Smith Companies Dental Products04/05/1996SE
K955643Alara Imaging SystemEGY · Traditional Denoptix, Inc.03/01/1996SE
K945682Processor, Radiographic-Film, Automatic, DentalEGY · Traditional Gendex Corp.02/09/1995SE
K900156AP201 Dental X-Ray Film ProcessorEGY · Traditional Allied Photo Products Co., Inc.05/14/1990SE
K874118Model 410 Dental X-Ray Film ProcessorsEGY · Traditional Dent-X Co.11/06/1987SE
K771433Auto. Devel. Unit Foo Dental X-RayEGY · Traditional Ada Products Co., Inc.08/19/1977SE
K770783Film Processor, AutomaticEGY · Traditional General Electric Co.05/10/1977SE

More from General Electric Co.

510(k)DeviceDecision
K965072Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray UnitEHD · Traditional 01/27/1997SE
K931717Yoshida/Kaycor X-707 Wall Mounted Dental X-RayEAP · Traditional 09/20/1993SE
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

Questions and answers

When was Yoshida Ap 100 cleared by the FDA?

Yoshida Ap 100 (K811211) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 43 days after the submission was received.

What is the product code of K811211?

The FDA product code is EGY – Processor, Radiographic-Film, Automatic, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1900.