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510(k) K780334

ADHESIVE, BRACKET AND CONDITIONER RESIN by Rocky Mountain Orthodontics, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1978
Date Received
February 28, 1978
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)
  • K843527 — ORTHOMITE 111 ADHESIVE (October 18, 1984)
  • K780678 — IMPRESSION TRAY (April 28, 1978)
  • K780170 — ORTHODONTIC BRACKET PADS (March 15, 1978)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

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