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510(k) K250806

Dental Implant System by A.B. Dental Devices , Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
March 17, 2025
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 A.B. Dental Devices , Ltd.

  • K132125 — A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM (January 21, 2014)
  • K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES (April 18, 2012)
  • K051719 — A.B. DENTAL DEVICES (March 21, 2006)

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