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510(k) K971594

FLOW-RITE by Pulpdent Corp. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1997
Date Received
May 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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)

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