Osteomed Orthodontic Screw System
FDA 510(k) K031936 · Osteomed LP
510(k) numberK031936
Submission
- Device name
- Osteomed Orthodontic Screw System
- Applicant
- Osteomed LP
Addison, TX, US - Received
- June 23, 2003
- Decision date
- January 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Dentis Co., Ltd.
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| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
Questions and answers
When was Osteomed Orthodontic Screw System cleared by the FDA?
Osteomed Orthodontic Screw System (K031936) received a 510(k) decision of Substantially Equivalent on January 7, 2004, 198 days after the submission was received.
What is the product code of K031936?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.