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510(k) K852170

EZX YELLOW, BLUE OR ORANGE by Strong Marketing — Product Code EGZ

K852170 is an FDA 510(k) premarket notification submitted by Strong Marketing for the device "EZX YELLOW, BLUE OR ORANGE". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
May 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Film, X-Ray
Device Class
Class I
Regulation Number
872.1905
Review Panel
DE
Submission Type

Other clearances for product code EGZ

  • K913160 — ID-TAB (September 6, 1991)
  • K913168 — SALIBAG (September 6, 1991)
  • K890355 — DENTAL X-RAY BITE BLOCK (June 12, 1989)
  • K853451 — TROLL-BITE (January 21, 1986)
  • K853005 — S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (August 13, 1985)
  • K813378 — UNI-BITE DENTAL X-RAY FILM HOLDER (January 29, 1982)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)

FDA data resources