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510(k) K010611

R & D DESIGNATION AP-047 by Jensen Industries, Inc. — Product Code EJT

K010611 is an FDA 510(k) premarket notification submitted by Jensen Industries, Inc. for the device "R & D DESIGNATION AP-047". The FDA issued a decision of Substantially Equivalent on March 27, 2001. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Jensen Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2001
Date Received
March 1, 2001
Clearance Type
Abbreviated
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 Jensen Industries, Inc.

  • K183408 — Jensen Shade Effect Liquids (March 20, 2019)
  • K142043 — INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA (December 18, 2014)
  • K112806 — JENSEN ZIRCONIA (December 1, 2011)
  • K111743 — THE INSYNC CERAMIC SYSTEM (September 14, 2011)
  • K070114 — CREATION CP-ZI PORCELAIN (March 1, 2007)
  • K050838 — THE LF-P CERAMIC SYSTEM (May 4, 2005)
  • K043201 — WILLI GELLER CREATION ZI PORCELAIN (January 11, 2005)
  • K043221 — WILLI GELLER CREATION CP PORCELAIN (December 20, 2004)
  • K032267 — R&D DESIGNATION AP-052-5 (September 17, 2003)
  • K022206 — JENSEN GOLD FOIL (August 29, 2002)

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