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510(k) K920692

SEPTOCALCINE ULTRA by Specialites Septodont — Product Code EJK

K920692 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "SEPTOCALCINE ULTRA". The FDA issued a decision of Substantially Equivalent on April 21, 1992. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Specialites Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
February 14, 1992
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 Specialites Septodont

  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K010415 — ISODAN (July 23, 2001)
  • K982773 — QUICKSET LIQUID AND POWDER (November 3, 1998)
  • K982671 — SECURALLOY (October 19, 1998)
  • K980633 — ENDOSOLV E (May 1, 1998)
  • K915466 — SEPTOPACK TEMPORARY FILLING (February 3, 1992)
  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
  • K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE (November 7, 1991)
  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)
  • K913574 — SEPTOCAL CAVITY LINER (September 30, 1991)

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)

FDA data resources