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510(k) K850776

PREFORMED DENTAL IMPRESSION TRAYS by L.A.K. Ent., Inc. — Product Code EHY

K850776 is an FDA 510(k) premarket notification submitted by L.A.K. Ent., Inc. for the device "PREFORMED DENTAL IMPRESSION TRAYS". The FDA issued a decision of Substantially Equivalent on March 18, 1985. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. L.A.K. Ent., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1985
Date Received
February 26, 1985
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 L.A.K. Ent., Inc.

  • K850775 — DENTAL MASSAGING PICKS (April 10, 1985)

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)
  • 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)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)
  • K810524 — SR-IVOTRAY SPECIAL (March 17, 1981)

FDA data resources