Home / 510(k) Clearances / K955825

510(k) K955825

SMITH S-100 TIME & TEMPERATURE CONTROL by Smith Companies Dental Products — Product Code EGY

K955825 is an FDA 510(k) premarket notification submitted by Smith Companies Dental Products for the device "SMITH S-100 TIME & TEMPERATURE CONTROL". The FDA issued a decision of Substantially Equivalent on April 5, 1996. 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
April 5, 1996
Date Received
December 26, 1995
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)
  • 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)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources