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510(k) K030146

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

K030146 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+". The FDA issued a decision of Substantially Equivalent on August 3, 2005. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Kavo America has at least 10 other 510(k) clearances on record.

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.

Other clearances by Kavo America

  • K073074 — KEY LASER III 1243 US WITH DETECT (July 10, 2008)
  • K072262 — GENTLERAY 980 DIODE LASER SYSTEM (October 26, 2007)
  • K063624 — KAVO EVEREST C-TEMP (February 8, 2007)
  • K051909 — DIAGNODENT (October 21, 2005)
  • K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (January 31, 2005)
  • K032081 — KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 (July 24, 2003)
  • K031868 — PROPHYPEARLS (July 9, 2003)
  • K030607 — KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND (May 2, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)
  • K012308 — KAVO QUATTROCARE (June 26, 2002)

Other clearances for product code NVK

  • K253309 — SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers th (May 19, 2026)
  • K260765 — Gemini NOVA 810+980 Soft Tissue Laser (March 10, 2026)
  • K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30) (October 16, 2025)
  • K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (May 8, 2025)
  • K230047 — Medical Diode Laser Systems (March 4, 2024)
  • K232885 — Dawn Diode Laser System (February 28, 2024)
  • K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Trip (November 27, 2023)
  • K221761 — Solea (September 14, 2022)
  • K211150 — Dental diode laser, SOGA Laser, ILaser II (July 1, 2022)
  • K214008 — Dental diode laser (May 10, 2022)

FDA data resources