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510(k) K191524

Visalys Tooth Primer by Kettenbach GmbH & Co. KG — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2019
Date Received
June 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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  • K143104 — Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (March 25, 2015)
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  • 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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