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510(k) K833485

IMPRESSION TUBE ADJUSTABLE by Zefr, Inc. — Product Code EHY

K833485 is an FDA 510(k) premarket notification submitted by Zefr, Inc. for the device "IMPRESSION TUBE ADJUSTABLE". The FDA issued a decision of Substantially Equivalent on December 26, 1983. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1983
Date Received
October 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Impression, Preformed
Device Class
Class I
Regulation Number
872.6880
Review Panel
DE
Submission Type

Other clearances for product code EHY

  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K896470 — EOS IMPRESSION TRAYS (February 9, 1990)
  • K884316 — OCCLUSAL HARMONY IMPRESSION TRAY (December 22, 1988)
  • K863836 — POST TRAY (October 14, 1986)
  • K850776 — PREFORMED DENTAL IMPRESSION TRAYS (March 18, 1985)
  • K842274 — F-G-P TRAY (July 31, 1984)
  • K842273 — CROWN INDEX TRAY (July 31, 1984)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • K810524 — SR-IVOTRAY SPECIAL (March 17, 1981)

FDA data resources