Home / 510(k) Clearances / K881789

510(k) K881789

MINILINE BRACKET by Alexotek Co. — Product Code EJF

K881789 is an FDA 510(k) premarket notification submitted by Alexotek Co. for the device "MINILINE BRACKET". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code EJF (Bracket, Metal, 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
June 1, 1988
Date Received
April 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Alexotek Co.

  • K834446 — ALEXOTEK LINGUAL TUBES (April 5, 1984)
  • K834392 — LABIAL CUSPID TUBE (February 28, 1984)
  • K834272 — ALEXOLOK BRACKET (February 3, 1984)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources