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510(k) K031811

PIT & FISSURE SEALANT WITH FLUORIDE by Harry J. Bosworth Co. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2003
Date Received
June 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Harry J. Bosworth Co.

  • K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP (March 4, 2011)
  • K100731 — BOSWORTH AIR POLISHER (December 3, 2010)
  • K061611 — BOSWORTH DENTIN RESIN (September 11, 2006)
  • K051224 — BOSWORTH SEAL (July 28, 2005)
  • K043170 — BOSWORTH BOND (February 25, 2005)
  • K040548 — AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE (March 19, 2004)
  • K040547 — AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE (March 19, 2004)
  • K033751 — AEGIS PIT & FISSURE SEALANT WITH ACP (February 5, 2004)
  • K031439 — ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) (October 2, 2003)
  • K994027 — ACTIVATOR PASTE (April 13, 2000)

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