Home / 510(k) Clearances / K162043

510(k) K162043

NobelProcera HT ML FCZ Bridge by Nobel Biocare AB — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2016
Date Received
July 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

Other clearances by Nobel Biocare AB

  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K243834 — NobelZygoma TiUltra Implant system (August 25, 2025)
  • K240346 — NobelProcera Zirconia Implant Bridge (January 3, 2025)
  • K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (January 24, 2024)
  • K231898 — DTX Studio Clinic (4.0) (December 8, 2023)
  • K223677 — Titanium Abutment Blank Nobel Biocare N1 TCC (April 28, 2023)
  • K221921 — DTX Studio Clinic 3.0 (March 28, 2023)
  • K213562 — DTX Studio Clinic 3.0 (March 25, 2022)
  • K212125 — Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (September 24, 2021)
  • K202452 — NobelProcera Zirconia Implant Bridge (December 3, 2020)

Other clearances for product code ELL

  • K240586 — Additive Manufacturing Zirconia Customized Restoration (October 3, 2024)
  • K203072 — Franz Zirconia Dental Crown (January 19, 2022)
  • K153534 — NobelProcera HT ML Full Contour Zirconia Crown (June 6, 2016)
  • K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (July 11, 2007)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
  • K041283 — PROCERA BRIDGE ZIRCONIA (May 28, 2004)
  • K032562 — PROCEARA COPINGS AND PONTIC (February 6, 2004)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (March 15, 1996)