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510(k) K033435

E-SARANG 86, DM78, DM55 by We Dong Myung Dental Industrial Co., Ltd. — Product Code EJT

K033435 is an FDA 510(k) premarket notification submitted by We Dong Myung Dental Industrial Co., Ltd. for the device "E-SARANG 86, DM78, DM55". The FDA issued a decision of Substantially Equivalent on November 12, 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 12, 2003
Date Received
October 28, 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.

  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 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)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)
  • K032319 — CERA R PLUS ALLOY (September 30, 2003)

FDA data resources