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510(k) K874118

MODEL 410 DENTAL X-RAY FILM PROCESSORS by Dent-X Co. — Product Code EGY

K874118 is an FDA 510(k) premarket notification submitted by Dent-X Co. for the device "MODEL 410 DENTAL X-RAY FILM PROCESSORS". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code EGY (Processor, Radiographic-Film, Automatic, Dental), a Class II device regulated under 21 CFR 892.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1987
Date Received
October 9, 1987
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 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)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources