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510(k) K043301

GC TION GINGIVAL PROTECTOR by GC America, Inc. — Product Code EIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2005
Date Received
November 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

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Other clearances for product code EIE

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  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
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