Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact
FDA 510(k) K082560 · Kettenbach GmbH & Co. KG
510(k) numberK082560
Submission
- Device name
- Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact
- Applicant
- Kettenbach GmbH & Co. KG
D-35713 Eschenburg, DE - Received
- September 4, 2008
- Decision date
- September 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact cleared by the FDA?
Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (K082560) received a 510(k) decision of Substantially Equivalent on September 8, 2008, 4 days after the submission was received.
What is the product code of K082560?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.