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510(k) K780384

IMPROVED DYCAL by L.D. Caulk Co. — Product Code EJK

K780384 is an FDA 510(k) premarket notification submitted by L.D. Caulk Co. for the device "IMPROVED DYCAL". The FDA issued a decision of Substantially Equivalent on March 15, 1978. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. L.D. Caulk Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1978
Date Received
March 9, 1978
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 L.D. Caulk Co.

  • K802262 — COMPOSITE RESTORATIVE (September 16, 1980)
  • K801690 — VALIANT (August 13, 1980)
  • K790585 — FINESSE (May 16, 1979)
  • K790586 — CHEMBOND (May 16, 1979)
  • K780560 — DENTAL AMALGAMATOR (April 21, 1978)
  • K780301 — CAULK TYLOK (February 28, 1978)
  • K771398 — SHELL VENEER (August 26, 1977)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K771401 — PROPHY PASTE (August 22, 1977)

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