Restore TPS Lhex Cylinder Endosseous Implant System
FDA 510(k) K944069 · Lifecore Biomedical, Inc.
510(k) numberK944069
Submission
- Device name
- Restore TPS Lhex Cylinder Endosseous Implant System
- Applicant
- Lifecore Biomedical, Inc.
Chaska, MN, US - Received
- August 18, 1994
- Decision date
- February 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Restore TPS Lhex Cylinder Endosseous Implant System cleared by the FDA?
Restore TPS Lhex Cylinder Endosseous Implant System (K944069) received a 510(k) decision of Substantially Equivalent on February 28, 1995, 194 days after the submission was received.
What is the product code of K944069?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.