Home / 510(k) Clearances / K131068

510(k) K131068

TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID by Kuraray Noritake Dental, Inc. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2013
Date Received
April 17, 2013
Clearance Type
Traditional
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 Kuraray Noritake Dental, Inc.

  • K250673 — CERABIEN MiLai (May 29, 2025)
  • K233285 — KATANA Zirconia ONE For IMPLANT (May 24, 2024)
  • K231039 — CLEARFIL Universal Bond Quick 2 (December 13, 2023)
  • K220369 — Esthetic Colorant (September 23, 2022)
  • K213147 — CERABIEN MiLai (March 28, 2022)
  • K210504 — PANAVIA Veneer LC (June 11, 2021)
  • K193060 — Noritake Super Porcelain EX-3 (January 30, 2020)
  • K191980 — CLEARFIL MAJESTY ES Flow (November 18, 2019)
  • K191133 — KATANA Cleaner, KATANA Cleaner (Trial) (October 8, 2019)
  • K190436 — KATANA Zirconia Block (May 23, 2019)

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)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)