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510(k) K102456

INTRAORAL BELSENSOR GOLD by Takara Belmont USA, Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2011
Date Received
August 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Takara Belmont USA, Inc.

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  • K042260 — PHOT-X II, MODEL 303 (September 7, 2004)
  • K040748 — ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM (June 2, 2004)

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