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510(k) K022522

PULPDENT PUTTY DAM by Pulpdent Corporation — Product Code EIE

K022522 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "PULPDENT PUTTY DAM". The FDA issued a decision of Substantially Equivalent on September 26, 2002. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Pulpdent Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2002
Date Received
July 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Pulpdent Corporation

  • K210045 — ACTIVA PRESTO PACK (September 22, 2021)
  • K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP (January 17, 2018)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K153249 — Pulpdent Solo Flowable Composite with MCP (April 1, 2016)
  • K130223 — RMGI FILL (March 29, 2013)
  • K123265 — RMGI LOW VISCOSITY (December 7, 2012)
  • K120784 — TUFF-TEMP 2.0 (June 8, 2012)
  • K120003 — NUCAL (April 5, 2012)
  • K120213 — ETCH-RITE SUPREME (March 30, 2012)
  • K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (March 21, 2012)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources