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510(k) K022025

MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT by Milton Hodosh, M.D. — Product Code EJK

K022025 is an FDA 510(k) premarket notification submitted by Milton Hodosh, M.D. for the device "MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT". The FDA issued a decision of Substantially Equivalent on August 15, 2002. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Milton Hodosh, M.D. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2002
Date Received
June 20, 2002
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 Milton Hodosh, M.D.

  • K032175 — DESENS-IONOMER (October 9, 2003)
  • K031721 — COMPOSITE RESTORATION MATERIAL (September 11, 2003)
  • K925207 — GLASS IONOMER CEMENT (July 8, 1993)
  • K905582 — POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND (April 29, 1991)
  • K895988 — POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL (March 7, 1990)
  • K882417 — POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT (February 13, 1989)

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