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510(k) K990699

ORTHO-GLOW GLITTER by Harry J. Bosworth Co. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1999
Date Received
March 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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)
  • K031811 — PIT & FISSURE SEALANT WITH FLUORIDE (September 4, 2003)

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