Home / 510(k) Clearances / K250267

510(k) K250267

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) by Kettenbach GmbH & Co. KG — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
January 30, 2025
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 Kettenbach GmbH & Co. KG

  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)
  • K191527 — Visalys CemCore, Visalys Cem Core Try In Paste (November 8, 2019)
  • K191523 — Visalys Restorative Primer (October 9, 2019)
  • K191524 — Visalys Tooth Primer (September 29, 2019)
  • K143104 — Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (March 25, 2015)
  • K122039 — KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (December 27, 2012)
  • K113279 — IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDEN (November 14, 2011)
  • K092867 — IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT (October 1, 2009)
  • K083701 — PANASIL INITIAL CONTACT AND PANASIL TRAY (January 9, 2009)
  • K082560 — PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CON (September 8, 2008)

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)