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510(k) K043170

BOSWORTH BOND by Harry J. Bosworth Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2005
Date Received
November 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
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)
  • K040547 — AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE (March 19, 2004)
  • K040548 — AEGIS ORTHO LIGHT-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)
  • K031811 — PIT & FISSURE SEALANT WITH FLUORIDE (September 4, 2003)
  • K994027 — ACTIVATOR PASTE (April 13, 2000)

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