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510(k) K093338

SELF ADHESIVE COMPOSITE LUTING CEMENT by Dmg USA, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2010
Date Received
October 23, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
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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