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510(k) K091647

INJECTAFIL by Apex Dental Materials, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2009
Date Received
June 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K092539 — SEAMFREE (October 1, 2009)
  • K062157 — CONFORM (October 13, 2006)
  • K061981 — SURPASS (July 31, 2006)
  • K053103 — INTERFACE (February 1, 2006)

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