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510(k) K020115

PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM by Pulpdent Corp. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2002
Date Received
January 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

Other clearances by Pulpdent Corp.

  • K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE (March 14, 2002)
  • K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT (March 14, 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)
  • K974398 — PULPDENT CAVITY VARNISH (February 18, 1998)

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