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510(k) K033446

APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 by We Dong Myung Dental Industrial Co., Ltd. — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2003
Date Received
October 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 We Dong Myung Dental Industrial Co., Ltd.

  • K033434 — BESTALOY (November 12, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K030206 — APEX 90 (January 29, 2003)

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)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)
  • K032321 — CERA F ALLOY (September 30, 2003)