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510(k) K934783

KAVO INTRASEPT 905 by Kavo America — Product Code EIA

K934783 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO INTRASEPT 905". The FDA issued a decision of Substantially Equivalent on May 16, 1994. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1994
Date Received
October 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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)
  • K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (August 3, 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)

Other clearances for product code EIA

  • K251626 — Midmark Dental Delivery System (November 3, 2025)
  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K242611 — Integral Dental Units (May 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 2025)
  • K242404 — BDC Dental Unit (February 7, 2025)
  • K231297 — Firstar Dental Unit (January 27, 2025)
  • K233805 — K5 (September 3, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231845 — Dental unit Model: Mare (February 28, 2024)

FDA data resources