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510(k) K982692

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC by Sterngold/Implamed — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1998
Date Received
August 3, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Sterngold/Implamed

  • K984341 — STERNVANTAGE VARNISH LC, MODEL 221001 (January 8, 1999)
  • K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 (January 8, 1999)
  • K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INS (November 13, 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)
  • K962302 — PEGASUS DENTAL ALLOY (July 18, 1996)

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