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510(k) K072055

LAVA FRAME, LAVA FRAME SHADE by 3M Espe AG Dental Products — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2008
Date Received
July 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by 3M Espe AG Dental Products

  • K100908 — UNICEM HM (June 22, 2010)
  • K100756 — MALTA (June 2, 2010)
  • K094007 — UNICEM (April 8, 2010)
  • K093721 — COSP2 (February 19, 2010)
  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K080514 — PECD-01 AND PECD QUICK-01 (March 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)
  • K071260 — HERMES BOND 3 (July 17, 2007)

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