Home / 510(k) Clearances / K982259

510(k) K982259

CHROMA ZONE COLOR STAIN by Kuraray America, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
June 26, 1998
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 Kuraray America, Inc.

  • K111982 — CLEARFIL DC CORE PLUS (November 17, 2011)
  • K111980 — CLEARFIL TRI-S BOND PLUS (October 14, 2011)
  • K063595 — CLEARFIL MAJESTY POSTERIOR (February 9, 2007)
  • K063593 — CLEARFIL MAJESTY FLOW (February 2, 2007)
  • K063228 — SURFACE COAT (December 8, 2006)
  • K002322 — MODIFICATION TO PANAVIA F (September 18, 2000)
  • K983361 — PANAVIA F (November 13, 1998)
  • K982164 — ESTENIA (August 10, 1998)
  • K974486 — CLEARFIL LINER BOND 2V (January 29, 1998)
  • K974089 — ALLOY PRIMER (December 17, 1997)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)