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510(k) K920460

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL by Pulpdent Corp. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1992
Date Received
January 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

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  • K013411 — PULPDENT CAVITY PREPARATION IV (December 12, 2001)
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  • K993683 — PULPDENT UNO-DUO (December 13, 1999)
  • K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS (March 19, 1998)

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