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510(k) K991631

FASTRAY LC by Harry J. Bosworth Co. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1999
Date Received
May 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Harry J. Bosworth Co.

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  • 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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