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510(k) K973372

AUROFILM 2000 by Metalor Dental USA Corp. — Product Code EJT

K973372 is an FDA 510(k) premarket notification submitted by Metalor Dental USA Corp. for the device "AUROFILM 2000". The FDA issued a decision of Substantially Equivalent on November 26, 1997. 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
November 26, 1997
Date Received
September 8, 1997
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)
  • K993506 — PAGALINOR 4 , ALLOY NO. 5440 (December 8, 1999)
  • K993505 — V-DELTA SPECIAL, ALLOY NO. 5154 (December 8, 1999)
  • K993507 — V-SUPRAGOLD, ALLOY NO. 5024 (December 6, 1999)
  • K993508 — V-SUPRA PLUS, ALLOY NO. 5025 (December 6, 1999)
  • K993474 — DELTAPAL, ALLOY NO. 5161 (December 2, 1999)
  • K982606 — AUROFLUID CPF (October 15, 1998)
  • K972683 — V-DELTA 450 (August 18, 1997)
  • K970045 — SOLARO 33 (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