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510(k) K990056

JELDENT MULTICRYL by J.F. Jelenko & Co., Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1999
Date Received
January 7, 1999
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 J.F. Jelenko & Co., Inc.

  • K012303 — JEL-20 (August 22, 2001)
  • K002993 — HERACERAM (November 16, 2000)
  • K002645 — JEL BIOS PURE (October 19, 2000)
  • K002222 — RD-2104 (August 31, 2000)
  • K001360 — SIGNUM (June 20, 2000)
  • K001260 — ALLROUND 55 LF (May 17, 2000)
  • K001196 — JEL BIOS 90 (CODE NAME RD-2401) (May 11, 2000)
  • K000532 — JEL 15 (April 6, 2000)
  • K993152 — JEL BIOS 18 (CODE NAME RD- 1214) (October 21, 1999)
  • K993136 — JEL BIOS 10 (CODE NAME RD-1801) (October 21, 1999)

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  • 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)