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510(k) K241462

LONGY Implant and LONGY-N Implant by Noris Medical , Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2025
Date Received
May 23, 2024
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

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  • K151909 — Noris Medical Zygomatic Dental Implant System (April 8, 2016)
  • K140440 — NORIS MEDICAL DENTAL IMPLANTS SYSTEM (December 19, 2014)

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