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510(k) K951785

PRIMALLOR 2 by Degussa Corp. — Product Code EJT

K951785 is an FDA 510(k) premarket notification submitted by Degussa Corp. for the device "PRIMALLOR 2". The FDA issued a decision of Substantially Equivalent on June 6, 1995. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Degussa Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1995
Date Received
April 17, 1995
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 Degussa Corp.

  • K973288 — STABILOR HN (November 19, 1997)
  • K972910 — PORS ON LITE (October 14, 1997)
  • K960256 — DEGUDENT LS (February 21, 1996)
  • K960226 — DG 88 (February 14, 1996)
  • K960104 — BIOCCLUS 4 (February 6, 1996)
  • K955465 — DEGUPRINT (December 28, 1995)
  • K955118 — DEGUBOND X-LITE PLUS (December 11, 1995)
  • K955027 — DEGUBOND X-LITE (December 1, 1995)
  • K953344 — DEGUBOND ULTRA (August 25, 1995)
  • K951789 — PALLIAG NF IV (June 14, 1995)

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