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510(k) K171772

Ecosite Bulk Fill by Dmg USA, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2018
Date Received
June 14, 2017
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

Other clearances by Dmg USA, Inc.

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  • K102603 — SA FLOWABLE ADHESIVE (November 17, 2010)
  • K101710 — LUXATEMP ULTRA /STAR (September 28, 2010)
  • K100062 — INFILTRATION KIT (March 26, 2010)
  • K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT (February 12, 2010)
  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)
  • K080480 — NANOCOMPOSITE RESTORATIVE KIT (May 30, 2008)

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