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510(k) K011491

HELIOSEAL CLEAR CHROMA by Ivoclar North America, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2001
Date Received
May 15, 2001
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 Ivoclar North America, Inc.

  • K012174 — ERIS LAYERING MATERIALS (August 27, 2001)
  • K011492 — IN TEN-S (July 5, 2001)
  • K011490 — MODIFICATION TO EXCITE (June 27, 2001)
  • K011022 — BIOUNIVERSAL PDF (May 2, 2001)
  • K011023 — D.SIGN 96 (May 2, 2001)
  • K010381 — D.SIGN 30 (March 6, 2001)
  • K010250 — TETRIC CERAM HB (February 28, 2001)
  • K003293 — EXCITE DSC (February 6, 2001)
  • K003407 — SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (January 26, 2001)
  • K003635 — DW 276 #3 (December 22, 2000)

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  • 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)