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510(k) K102603

SA FLOWABLE ADHESIVE by Dmg USA, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2010
Date Received
September 10, 2010
Clearance Type
Abbreviated
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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  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)
  • K080480 — NANOCOMPOSITE RESTORATIVE KIT (May 30, 2008)

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