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510(k) K961089

PULPDENT ENDOPREP II by Pulpdent Corp. — Product Code EKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
March 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Silver, Endodontic
Device Class
Class I
Regulation Number
872.3840
Review Panel
DE
Submission Type

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  • K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM (February 28, 2002)
  • K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE (February 27, 2002)
  • K013411 — PULPDENT CAVITY PREPARATION IV (December 12, 2001)
  • K994180 — PULPDENT CAVITY PREPARATION III (March 2, 2000)
  • K994181 — PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE (February 29, 2000)
  • K994182 — PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE (February 23, 2000)
  • K993683 — PULPDENT UNO-DUO (December 13, 1999)
  • K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS (March 19, 1998)

Other clearances for product code EKL

  • K992582 — PACIFIC IMPLANT TITANIUM ENDODONTIC POINT (October 21, 1999)
  • K822568 — EAR PROBES (September 14, 1982)