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510(k) K780205

ORTHODONTIC BUCCAL TUBE by Rocky Mountain Orthodontics, Inc. — Product Code DZD

K780205 is an FDA 510(k) premarket notification submitted by Rocky Mountain Orthodontics, Inc. for the device "ORTHODONTIC BUCCAL TUBE". The FDA issued a decision of Substantially Equivalent on February 16, 1978. The device falls under product code DZD (Tube, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Rocky Mountain Orthodontics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1978
Date Received
February 7, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Orthodontic
Device Class
Class I
Regulation Number
872.5410
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)
  • K780334 — ADHESIVE, BRACKET AND CONDITIONER RESIN (March 28, 1978)
  • K780170 — ORTHODONTIC BRACKET PADS (March 15, 1978)

Other clearances for product code DZD

  • K943421 — ORTHODONITC ELASTOMERIC SLEEVING (May 23, 1995)
  • K936243 — REGENCY TUBE (February 2, 1994)
  • K935143 — DENTAURUM STAINLESS STEEL TUBING (January 31, 1994)
  • K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (September 19, 1991)
  • K896586 — RATE INCREASE FOR IPPB/IPV (January 9, 1990)
  • K834446 — ALEXOTEK LINGUAL TUBES (April 5, 1984)
  • K834392 — LABIAL CUSPID TUBE (February 28, 1984)

FDA data resources