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510(k) K150559

Life Fast Set, Life Regular Set by Sybron Dental Specialties — Product Code EJK

K150559 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "Life Fast Set, Life Regular Set". The FDA issued a decision of Substantially Equivalent on June 19, 2015. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2015
Date Received
March 6, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
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)
  • K151332 — Nexus Universal, Nexus Universal Chroma (August 17, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)
  • K130869 — TAKE 1 ADVANCE (May 30, 2013)

Other clearances for product code EJK

  • K253248 — Bright Cavity Liner (January 13, 2026)
  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (May 13, 2022)
  • K201799 — CleaniCal (February 12, 2021)
  • K202413 — LC ResinCal PC (November 20, 2020)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
  • K143292 — TheraCal DC (August 4, 2015)
  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)
  • K134022 — BASE IT (June 11, 2014)

FDA data resources