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510(k) K143696

Spirit by Pelton & Crane — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2015
Date Received
December 24, 2014
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

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  • K960819 — HELIODENT DS (March 29, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 1995)
  • K936068 — ORTHOPHOS 3/ ORTHOPHOS 3C (July 29, 1994)

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