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510(k) K032319

CERA R PLUS ALLOY by Dentsply International — Product Code EJT

K032319 is an FDA 510(k) premarket notification submitted by Dentsply International for the device "CERA R PLUS ALLOY". The FDA issued a decision of Substantially Equivalent on September 30, 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2003
Date Received
July 28, 2003
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 Dentsply International

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

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