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510(k) K063444

TOTAL ETCH BONDING AGENT by Dmg USA, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2007
Date Received
November 15, 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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  • 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)

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