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510(k) K801208

HOLLOW BASKET TITANIUM DENTAL IMPLANT by Colmed, Ltd. — Product Code ELE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
May 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Subperiosteal
Device Class
Class II
Regulation Number
872.3645
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)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT (May 14, 1980)
  • K792241 — PELIMIT (November 30, 1979)

Other clearances for product code ELE

  • K210228 — KLS Martin IPS Preprosthetic (July 8, 2022)
  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K843557 — K-APATITE 20-40 MESH K-APATITE 40-60 (November 30, 1984)