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510(k) K800762

PS3 TITANIUM SCREW DENTAL IMPLANT by Colmed, Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 7, 1980
Clearance Type
Traditional
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 Colmed, Ltd.

  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K810636 — VARIODRAIN (May 1, 1981)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K792241 — PELIMIT (November 30, 1979)

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