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510(k) K041960

COMPOSITE/COMPOMER REPAIR KIT by Dmg USA, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2004
Date Received
July 21, 2004
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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  • K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT (February 12, 2010)
  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)

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