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510(k) K981516

STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB by Sterngold/Implamed — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1998
Date Received
April 28, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Sterngold/Implamed

  • K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 (January 8, 1999)
  • K984341 — STERNVANTAGE VARNISH LC, MODEL 221001 (January 8, 1999)
  • 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)
  • K962324 — STERNGOLD U-CPF METAL ALLOY (1067800) (July 24, 1996)
  • K962325 — QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) (July 24, 1996)
  • K962326 — STERNGOLD BIO-5 (1127210) (July 24, 1996)
  • K962304 — STERNGOLD BIO-4 (July 23, 1996)
  • K962303 — STERNGOLD CF (July 18, 1996)

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