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510(k) K834446

ALEXOTEK LINGUAL TUBES by Alexotek Co. — Product Code DZD

K834446 is an FDA 510(k) premarket notification submitted by Alexotek Co. for the device "ALEXOTEK LINGUAL TUBES". The FDA issued a decision of Substantially Equivalent on April 5, 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
April 5, 1984
Date Received
December 16, 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)
  • K834392 — LABIAL CUSPID TUBE (February 28, 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)
  • K834392 — LABIAL CUSPID TUBE (February 28, 1984)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

FDA data resources