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510(k) K780678

IMPRESSION TRAY by Rocky Mountain Orthodontics, Inc. — Product Code EHY

K780678 is an FDA 510(k) premarket notification submitted by Rocky Mountain Orthodontics, Inc. for the device "IMPRESSION TRAY". The FDA issued a decision of Substantially Equivalent on April 28, 1978. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Rocky Mountain Orthodontics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1978
Date Received
April 24, 1978
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 Rocky Mountain Orthodontics, Inc.

  • K895401 — NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM (December 4, 1989)
  • K843527 — ORTHOMITE 111 ADHESIVE (October 18, 1984)
  • K780334 — ADHESIVE, BRACKET AND CONDITIONER RESIN (March 28, 1978)
  • K780170 — ORTHODONTIC BRACKET PADS (March 15, 1978)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

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)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)

FDA data resources