Neodent Graft Screw
FDA 510(k) K103084 · Jjgc Industria E Comercio DE Materiais Dentarios S
510(k) numberK103084
Submission
- Device name
- Neodent Graft Screw
- Applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S
San Diego, CA, US - Received
- October 19, 2010
- Decision date
- February 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Hager& Meisinger GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K153624 | Neodent Implant SystemNHA · Traditional | 04/15/2016SE |
| K141777 | Neodent Implant SystemDZE · Traditional | 07/20/2015SE |
| K150367 | Neodent Implant SystemNHA · Traditional | 07/13/2015SE |
| K150199 | Neodent Implant SystemDZE · Traditional | 06/15/2015SE |
| K150182 | Neodent Implant System- CM Drive ImplantsDZE · Special | 04/23/2015SE |
| K133696 | Neodent Implant SystemNHA · Traditional | 02/25/2014SE |
| K123022 | Neodent Implant SystemDZE · Traditional | 05/17/2013SE |
| K102769 | Neodent Implant for Orthodontic AnchorageOAT · Traditional | 02/23/2011SE |
| K101945 | Neodent Implant SystemDZE · Traditional | 01/26/2011SE |
| K101207 | Neodent Implant SystemDZE · Traditional | 08/02/2010SE |
Questions and answers
When was Neodent Graft Screw cleared by the FDA?
Neodent Graft Screw (K103084) received a 510(k) decision of Substantially Equivalent on February 14, 2011, 118 days after the submission was received.
What is the product code of K103084?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.