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510(k) K050871

RIVA PROTECT by Southern Dental Industries, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2005
Date Received
April 6, 2005
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 Southern Dental Industries, Inc.

  • K062065 — RIVA LUTING PLUS (November 15, 2006)
  • K062064 — RIVA BOND LC (November 9, 2006)
  • K051008 — SET (June 15, 2005)
  • K050870 — RIVA LIGHT CURE (June 3, 2005)
  • K050331 — ADHESIVE 1 (March 24, 2005)
  • K042452 — RIVA SILVER (December 7, 2004)
  • K040393 — RIVA LUTING (April 30, 2004)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K031658 — BENCO SPHERICAL (July 29, 2003)
  • K030568 — RADII (April 24, 2003)

Other clearances for product code EBC

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  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)