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510(k) K081699

PLANMECA SOVEREIGN by Planmeca USA, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2008
Date Received
June 17, 2008
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 Planmeca USA, Inc.

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  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K923462 — DELIGHT (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904947 — PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (January 30, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 1986)
  • K842359 — AUTOMATIC PATIENT CHAIR PM2000 & A (September 19, 1984)

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