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510(k) K191527

Visalys CemCore, Visalys Cem Core Try In Paste by Kettenbach GmbH & Co. KG — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2019
Date Received
June 10, 2019
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

Other clearances by Kettenbach GmbH & Co. KG

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  • K191523 — Visalys Restorative Primer (October 9, 2019)
  • K191524 — Visalys Tooth Primer (September 29, 2019)
  • K143104 — Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (March 25, 2015)
  • K122039 — KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (December 27, 2012)
  • K113279 — IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDEN (November 14, 2011)
  • K092867 — IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT (October 1, 2009)
  • K083701 — PANASIL INITIAL CONTACT AND PANASIL TRAY (January 9, 2009)
  • K082560 — PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CON (September 8, 2008)

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