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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

K033446 is an FDA 510(k) premarket notification submitted by We Dong Myung Dental Industrial Co., Ltd. for the device "APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82". The FDA issued a decision of Substantially Equivalent on November 13, 2003. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. We Dong Myung Dental Industrial Co., Ltd. has at least 3 other 510(k) clearances on record.

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.

  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K033434 — BESTALOY (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)
  • K032316 — ORION E ALLOY (September 30, 2003)

FDA data resources