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510(k) K780263

SHIELD by Lorvic Corp. — Product Code EJK

K780263 is an FDA 510(k) premarket notification submitted by Lorvic Corp. for the device "SHIELD". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Lorvic Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
February 17, 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 Lorvic Corp.

  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)
  • K770063 — DISP. ABSORBENT COMPRESSED FIBRE WAFER (January 14, 1977)
  • K760620 — SALIVA EJECTOR (September 21, 1976)
  • K760121 — IMPULSE HEAT SEALER (July 16, 1976)

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