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510(k) K171189

AIR-FLOW PLUS Prophylaxis powder by E.M.S Electro Medical Systems S.A — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2017
Date Received
April 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

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Other clearances for product code EJR

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  • K103114 — OSSPRAY SYLC CR (March 14, 2011)
  • K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE (February 3, 2011)
  • K101104 — REMIN PRO (October 21, 2010)
  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)
  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K042048 — GELATO PROPHYLAXIS PASTE (October 26, 2004)