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510(k) K030146

KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ by Kavo America — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2005
Date Received
January 15, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Dental, Soft Tissue
Device Class
Class II
Regulation Number
878.4810
Review Panel
DE
Submission Type

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

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  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)
  • K012308 — KAVO QUATTROCARE (June 26, 2002)

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