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510(k) K001360

SIGNUM by J.F. Jelenko & Co., Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2000
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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)
  • K991564 — JELTEMP (June 23, 1999)

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