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510(k) K210259

Parkell Self-Adhesive Cement by Parkell, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2022
Date Received
February 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (April 12, 2012)
  • K101044 — RETRIEVE IMPLANT CEMENT (June 10, 2010)

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