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510(k) K842273

CROWN INDEX TRAY by Di-Equi Dental Products — Product Code EHY

K842273 is an FDA 510(k) premarket notification submitted by Di-Equi Dental Products for the device "CROWN INDEX TRAY". The FDA issued a decision of Substantially Equivalent on July 31, 1984. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Di-Equi Dental Products has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1984
Date Received
June 8, 1984
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 by Di-Equi Dental Products

  • K842274 — F-G-P TRAY (July 31, 1984)

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)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)
  • K810524 — SR-IVOTRAY SPECIAL (March 17, 1981)

FDA data resources