Home / 510(k) Clearances / K141081

510(k) K141081

FILTEK BULK FILL POSTERIOR RESTROATIVE by 3M Espe Dental Products — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2014
Date Received
April 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by 3M Espe Dental Products

  • K231338 — 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (May 10, 2023)
  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K191122 — 3M RelyX Pediatric Resin Modified Glass Ionomer Cement (May 29, 2019)
  • K183476 — 3M Filtek Universal Restorative (January 2, 2019)
  • K120453 — FILTEK BULK FILL FLOWABLE RESTORATIVE (March 19, 2012)
  • K111185 — RELYX LUTING PLUS AUTOMIX (May 5, 2011)
  • K110131 — LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN R (January 21, 2011)
  • K092141 — VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH (March 10, 2010)
  • K073395 — GILB-2, GLASS IONOMER PROTECTIVE COATING (January 17, 2008)
  • K070956 — SEA2 SELF ETCH ADHESIVE (May 22, 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)