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510(k) K831098

DOMINION by Unitek Corp. — Product Code EJT

K831098 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "DOMINION". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Unitek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
April 4, 1983
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 Unitek Corp.

  • K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET (November 29, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K940165 — ALASTIK (March 7, 1994)
  • K923999 — ALASTIK NS (June 24, 1993)
  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K924295 — DEBRACKETING INSTRUMENT (November 23, 1992)
  • K923432 — GERMAN MINI DYNALOCK (October 30, 1992)
  • K911271 — ADHESIVE PRECOATED BRACKETS (May 29, 1991)
  • K910288 — NONSTAINING ALASTIKS (March 29, 1991)
  • K890529 — ALASTIGARD (March 9, 1989)

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