Restore Self Tapping Dental Implant Syst (5, 5.5,6MM)
FDA 510(k) K944068 · Lifecore Biomedical, Inc.
510(k) numberK944068
Submission
- Device name
- Restore Self Tapping Dental Implant Syst (5, 5.5,6MM)
- Applicant
- Lifecore Biomedical, Inc.
Chaska, MN, US - Received
- August 15, 1994
- Decision date
- February 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…ELL · Traditional | 05/22/2006SE |
| K053643 | Stage- 1 Temporary/Healing Cap, Model 42021-42026NHA · Special | 01/23/2006SE |
| K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…DZE · Abbreviated | 09/09/2005SE |
| K050506 | Primasolo One-Piece Implants & Healing CapsDZE · Abbreviated | 04/15/2005SE |
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Questions and answers
When was Restore Self Tapping Dental Implant Syst (5, 5.5,6MM) cleared by the FDA?
Restore Self Tapping Dental Implant Syst (5, 5.5,6MM) (K944068) received a 510(k) decision of Substantially Equivalent on February 2, 1995, 171 days after the submission was received.
What is the product code of K944068?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.