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510(k) K061981

SURPASS by Apex Dental Materials, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2006
Date Received
July 13, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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  • K092539 — SEAMFREE (October 1, 2009)
  • K091647 — INJECTAFIL (September 21, 2009)
  • K062157 — CONFORM (October 13, 2006)
  • K053103 — INTERFACE (February 1, 2006)

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