Home / 510(k) Clearances / K080068

510(k) K080068

BEAUTIFIL OPAQUER by Shofu Dental Corp. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2008
Date Received
January 10, 2008
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 Shofu Dental Corp.

  • K111855 — HY-BOND RESIGLASS (November 17, 2011)
  • K110235 — BEAUTIBOND MULTI (May 13, 2011)
  • K110252 — BEAUTIBOND MULTI PR PLUS (May 13, 2011)
  • K101621 — LITE ART (August 23, 2010)
  • K101603 — BEAUTIFIL FLOW PLUS (August 23, 2010)
  • K093559 — VINTAGE MP (March 3, 2010)
  • K082744 — BEAUTIBOND (December 11, 2008)
  • K080517 — RESICEM (June 11, 2008)
  • K080834 — VINTAGE ART (June 11, 2008)
  • K071742 — BEAUTIFIL II (August 15, 2007)

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)