Home / 510(k) Clearances / K840548

510(k) K840548

RESIL by Parker Laboratories, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
February 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Parker Laboratories, Inc.

  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K953673 — ECLIPSE PROBE COVER (March 14, 1996)
  • K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (February 23, 1995)
  • K864556 — AQUALUBE(TM) (December 1, 1986)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K831039 — COMPLUS VARIOUS FORMS (May 27, 1983)

Other clearances for product code EBI

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)