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510(k) K080074

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX by Ace Surgical Supply Co., Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2008
Date Received
January 11, 2008
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 Ace Surgical Supply Co., Inc.

  • K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM (January 14, 2010)
  • K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, (September 16, 2009)
  • K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX (March 13, 2008)
  • K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-910 (August 16, 2006)
  • K051381 — ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE (July 15, 2005)
  • K041759 — ACE CONNECT INTERNAL CONNECTION (July 22, 2004)
  • K021244 — ACE HA SCREW DENTAL IMPLANT SYSTEM (May 3, 2002)
  • K002075 — ACE SDS 3.75MM SCREW DENTAL IMPLANT (February 2, 2001)
  • K990140 — NORMED BONE TRANSPORT (March 25, 1999)
  • K981526 — ACE ALVEOLAR DISTRACTOR (November 6, 1998)

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