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510(k) K811211

YOSHIDA AP 100 by Kaycor Intl., Ltd. — Product Code EGY

K811211 is an FDA 510(k) premarket notification submitted by Kaycor Intl., Ltd. for the device "YOSHIDA AP 100". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code EGY (Processor, Radiographic-Film, Automatic, Dental), a Class II device regulated under 21 CFR 892.1900. Kaycor Intl., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
May 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic, Dental
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Kaycor Intl., Ltd.

  • K965072 — PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT (January 27, 1997)
  • K931717 — YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY (September 20, 1993)
  • K832063 — ROBIN CORDLESS HANDPIECE (August 26, 1983)
  • K822740 — K30000 DENTAL CHAIR (September 28, 1982)
  • K813348 — YOSHIDA RIDO-F, MODEL LM-01 (January 7, 1982)
  • K811210 — YOSHIDA-PANOURA 10 (August 24, 1981)

Other clearances for product code EGY

  • K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (September 3, 1999)
  • K955825 — SMITH S-100 TIME & TEMPERATURE CONTROL (April 5, 1996)
  • K955643 — ALARA IMAGING SYSTEM (March 1, 1996)
  • K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (February 9, 1995)
  • K900156 — AP201 DENTAL X-RAY FILM PROCESSOR (May 14, 1990)
  • K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS (November 6, 1987)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources