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510(k) K032851

ULTRACROWN 75 ALLOY by Dentsply International — Product Code EJT

K032851 is an FDA 510(k) premarket notification submitted by Dentsply International for the device "ULTRACROWN 75 ALLOY". The FDA issued a decision of Substantially Equivalent on Sep 26, 2003. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Dentsply International has 58 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 26, 2003
Date Received
Sep 12, 2003
Clearance Type
Special
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
510(k) Exempt

Other clearances by Dentsply International

  • K160207 — ATLANTIS ISUS Implant Suprastructures (Sep 21, 2016)
  • K160232 — Disposable Barrier Sleeves and Covers (Jun 7, 2016)
  • K151439 — ATLANTIS ISUS (Feb 19, 2016)
  • K152247 — ATLANTIS Crown (Jan 29, 2016)
  • K151039 — ATLANTIS Abutment for NobelActive 3.0 (Jan 14, 2016)
  • K151619 — Prime&Bond Elect Universal Dental Adhesive (Oct 30, 2015)
  • K150535 — Cavitron Touch Ultrasonic Scaling System (Jun 16, 2015)
  • K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY (Feb 26, 2015)
  • K131907 — RAYPEX 6 (Jan 31, 2014)
  • K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (Jan 22, 2014)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (Oct 14, 2005)
  • K041378 — BIO 60 (Aug 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (Mar 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C… (Mar 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (Jan 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (Nov 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (Nov 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (Oct 1, 2003)

FDA data resources