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510(k) K834392

LABIAL CUSPID TUBE by Alexotek Co. — Product Code DZD

K834392 is an FDA 510(k) premarket notification submitted by Alexotek Co. for the device "LABIAL CUSPID TUBE". The FDA issued a decision of Substantially Equivalent on February 28, 1984. The device falls under product code DZD (Tube, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Alexotek Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1984
Date Received
December 14, 1983
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 Alexotek Co.

  • K881789 — MINILINE BRACKET (June 1, 1988)
  • K834446 — ALEXOTEK LINGUAL TUBES (April 5, 1984)
  • K834272 — ALEXOLOK BRACKET (February 3, 1984)

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)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

FDA data resources