Home / 510(k) Clearances / K993716

510(k) K993716

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE by Harry J. Bosworth Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
November 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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)

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