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510(k) K982606

AUROFLUID CPF by Metalor Dental USA Corp. — Product Code EJT

K982606 is an FDA 510(k) premarket notification submitted by Metalor Dental USA Corp. for the device "AUROFLUID CPF". The FDA issued a decision of Substantially Equivalent on October 15, 1998. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Metalor Dental USA Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1998
Date Received
July 27, 1998
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 Metalor Dental USA Corp.

  • K003387 — AUROFILM NP (January 9, 2001)
  • K993475 — AUROFLUID M, ALLOY NO. 5315 (December 9, 1999)
  • K993505 — V-DELTA SPECIAL, ALLOY NO. 5154 (December 8, 1999)
  • K993506 — PAGALINOR 4 , ALLOY NO. 5440 (December 8, 1999)
  • K993508 — V-SUPRA PLUS, ALLOY NO. 5025 (December 6, 1999)
  • K993507 — V-SUPRAGOLD, ALLOY NO. 5024 (December 6, 1999)
  • K993474 — DELTAPAL, ALLOY NO. 5161 (December 2, 1999)
  • K973372 — AUROFILM 2000 (November 26, 1997)
  • K972683 — V-DELTA 450 (August 18, 1997)
  • K970044 — AUROFLUID 22 (March 5, 1997)

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