Home / 510(k) Clearances / K151332

510(k) K151332

Nexus Universal, Nexus Universal Chroma by Sybron Dental Specialties — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2015
Date Received
May 19, 2015
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Sybron Dental Specialties

  • K182826 — Ormco Spark Aligner System (October 11, 2018)
  • K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System (April 21, 2017)
  • K160097 — Image Fast Set, Image Regular Set (August 5, 2016)
  • K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (July 27, 2016)
  • K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT (May 6, 2016)
  • K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (April 14, 2016)
  • K151526 — Zone, ZoneFree, Zone A1 (September 10, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)
  • K130869 — TAKE 1 ADVANCE (May 30, 2013)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)