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510(k) K962071

SPIRIT S1/S2 by Pelton & Crane Co. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1996
Date Received
May 28, 1996
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)
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  • K950030 — HELIODENT MD (February 3, 1995)
  • K936068 — ORTHOPHOS 3/ ORTHOPHOS 3C (July 29, 1994)

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