Home / 510(k) Clearances / K882006

510(k) K882006

CLEARFIL PHOTO CORE by Kuraray Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1988
Date Received
May 13, 1988
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 Co.

  • K990040 — CLEARFIL SE BOND (February 4, 1999)
  • K951813 — CARIES DETECTOR (July 11, 1995)
  • K933030 — PANAVIA 21 (February 24, 1994)
  • K925383 — PHOTO CLEARFIL OPAQUER (January 28, 1993)
  • K925404 — CLEARFIL PORCELAIN BOND ACTIVATOR (January 11, 1993)
  • K912707 — CLEARFIL LINER BOND SYSTEM (August 20, 1991)
  • K912708 — CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM (August 20, 1991)
  • K910424 — TEETHMATE-F (April 3, 1991)
  • K900690 — CLEARFIL VENEER BOND KIT (April 13, 1990)
  • K897027 — TEETHMATE-A (March 14, 1990)

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)