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510(k) K843527

ORTHOMITE 111 ADHESIVE by Rocky Mountain Orthodontics, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
September 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

Other clearances by Rocky Mountain Orthodontics, Inc.

  • K895401 — NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM (December 4, 1989)
  • K780678 — IMPRESSION TRAY (April 28, 1978)
  • K780334 — ADHESIVE, BRACKET AND CONDITIONER RESIN (March 28, 1978)
  • K780170 — ORTHODONTIC BRACKET PADS (March 15, 1978)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

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