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510(k) K002645

JEL BIOS PURE by J.F. Jelenko & Co., Inc. — Product Code EJT

K002645 is an FDA 510(k) premarket notification submitted by J.F. Jelenko & Co., Inc. for the device "JEL BIOS PURE". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. J.F. Jelenko & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
August 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by J.F. Jelenko & Co., Inc.

  • K012303 — JEL-20 (August 22, 2001)
  • K002993 — HERACERAM (November 16, 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)
  • K993136 — JEL BIOS 10 (CODE NAME RD-1801) (October 21, 1999)
  • K993152 — JEL BIOS 18 (CODE NAME RD- 1214) (October 21, 1999)
  • K991564 — JELTEMP (June 23, 1999)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources