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510(k) K771433

AUTO. DEVEL. UNIT FOO DENTAL X-RAY by Ada Products Co., Inc. — Product Code EGY

K771433 is an FDA 510(k) premarket notification submitted by Ada Products Co., Inc. for the device "AUTO. DEVEL. UNIT FOO DENTAL X-RAY". The FDA issued a decision of Substantially Equivalent on August 19, 1977. 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
August 19, 1977
Date Received
August 1, 1977
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)
  • K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS (November 6, 1987)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources