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510(k) K950213

THE STERN ROOT ANCHOR SYSTEM by Sterngold/Implamed — Product Code ELR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1995
Date Received
January 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type

Other clearances by Sterngold/Implamed

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  • K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INS (November 13, 1998)
  • K982692 — STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC (October 22, 1998)
  • K982895 — STERNOMEGA COMPOMER CEMENT (October 9, 1998)
  • K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMP (May 11, 1998)
  • K962326 — STERNGOLD BIO-5 (1127210) (July 24, 1996)
  • K962325 — QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) (July 24, 1996)
  • K962324 — STERNGOLD U-CPF METAL ALLOY (1067800) (July 24, 1996)
  • K962304 — STERNGOLD BIO-4 (July 23, 1996)

Other clearances for product code ELR

  • K060075 — FIBER-METAL POST (March 30, 2006)
  • K042848 — FRC POSTEC PLUS (November 22, 2004)
  • K030820 — EVERSTICK POST (May 20, 2003)
  • K020431 — FIBIOCORE (July 3, 2002)
  • K012496 — CARBON POST (May 17, 2002)
  • K013802 — FRC POSTEC (May 1, 2002)
  • K012849 — GLASS POST (March 27, 2002)
  • K012354 — SNOWPOST, SNOWLIGHT (October 10, 2001)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)