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510(k) K140684

CLINPRO PROPHY POWDER by 3M Deutschland GmbH — Product Code PIP

K140684 is an FDA 510(k) premarket notification submitted by 3M Deutschland GmbH for the device "CLINPRO PROPHY POWDER". The FDA issued a decision of Substantially Equivalent on October 24, 2014. The device falls under product code PIP (Prophy Powder, Airbrush Accessory), a Class II device regulated under 21 CFR 872.6080. 3M Deutschland GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2014
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prophy Powder, Airbrush Accessory
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.

Other clearances by 3M Deutschland GmbH

  • K220257 — Permadyne (February 1, 2022)
  • K192992 — Suglue 3 (November 5, 2019)
  • K192961 — ADH19 (October 31, 2019)
  • K173318 — Rapid HB, Rapid LB, Rapid MB (October 31, 2017)
  • K161922 — XP202 (September 1, 2016)
  • K153174 — Ketac Universal Aplicap (April 13, 2016)
  • K151748 — Clean & More (March 11, 2016)
  • K151144 — SuPro 100 (September 14, 2015)
  • K133436 — FLASH AR; FLASH AR QUICK (March 7, 2014)
  • K131404 — FLASH AR PENTA / FLASH AR PENTA QUICK (May 30, 2013)

Other clearances for product code PIP

  • K151748 — Clean & More (March 11, 2016)

FDA data resources