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510(k) K191103

Parkell Desensitizer Gel by Parkell, Inc. — Product Code EJK

K191103 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "Parkell Desensitizer Gel". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Parkell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
April 25, 2019
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 Parkell, Inc.

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K210259 — Parkell Self-Adhesive Cement (January 20, 2022)
  • K190930 — SmarTemp X1 (September 5, 2019)
  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (April 12, 2012)
  • K101044 — RETRIEVE IMPLANT CEMENT (June 10, 2010)

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)
  • 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)
  • K134022 — BASE IT (June 11, 2014)

FDA data resources