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510(k) K993683

PULPDENT UNO-DUO by Pulpdent Corp. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1999
Date Received
November 1, 1999
Clearance Type
Traditional
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

Other clearances by Pulpdent Corp.

  • K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT (March 14, 2002)
  • K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE (March 14, 2002)
  • 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)
  • K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS (March 19, 1998)
  • K974398 — PULPDENT CAVITY VARNISH (February 18, 1998)

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