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510(k) K060530

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. by Lifecore Biomedical, Inc. — Product Code ELL

K060530 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.". The FDA issued a decision of Substantially Equivalent on May 22, 2006. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Lifecore Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2006
Date Received
February 28, 2006
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 Lifecore Biomedical, Inc.

  • K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (November 16, 2007)
  • K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM (November 9, 2007)
  • K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS (October 23, 2007)
  • K072572 — PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS (October 5, 2007)
  • K062876 — PRIMACONNEX CERAMIC ABUTMENTS (November 1, 2006)
  • K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 (January 23, 2006)
  • K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION (September 9, 2005)
  • K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (April 15, 2005)
  • K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (July 19, 2004)
  • K032774 — RENOVA INTERNAL HEX IMPLANT SYSTEM (November 26, 2003)

Other clearances for product code ELL

  • K240586 — Additive Manufacturing Zirconia Customized Restoration (October 3, 2024)
  • K203072 — Franz Zirconia Dental Crown (January 19, 2022)
  • K162043 — NobelProcera HT ML FCZ Bridge (November 22, 2016)
  • 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)
  • 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)

FDA data resources