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510(k) K872147

KERR CAVALITE by Kerr Corporation (Danbury) — Product Code EJK

K872147 is an FDA 510(k) premarket notification submitted by Kerr Corporation (Danbury) for the device "KERR CAVALITE". The FDA issued a decision of Substantially Equivalent on August 26, 1987. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Kerr Corporation (Danbury) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1987
Date Received
June 4, 1987
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 Kerr Corporation (Danbury)

  • K051545 — L.E. DEMETRON II (July 18, 2005)
  • K020091 — OPTILUX 501 (March 21, 2002)
  • K951663 — TYTIN R (June 6, 1995)
  • K951511 — TYTIN ADMIX (May 2, 1995)
  • K942480 — M4 CONTRA-ANGLE HANDPIECE (January 27, 1995)
  • K940513 — OPTIBOND (April 15, 1994)
  • K935535 — TYTIN (March 11, 1994)
  • K934690 — KERR OPTIBOND, MODIFICATION (December 30, 1993)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)

Other clearances for product code EJK

  • K261728 — One-Fil LC (July 21, 2026)
  • 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)

FDA data resources