HDC Sterile Self Ligating Spider Screw, Model SLI,SL2
FDA 510(k) K091390 · Hdc S.R.L.
510(k) numberK091390
Submission
- Device name
- HDC Sterile Self Ligating Spider Screw, Model SLI,SL2
- Applicant
- Hdc S.R.L.
Imola, Bologna, IT - Received
- May 11, 2009
- Decision date
- July 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAT – Implant, Endosseous, Orthodontic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3640
- Specialty
- Dental
- Implant
- Yes
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Other 510(k)s with product code OAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long NeckOAT · Traditional | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 05/19/2026SE |
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device)OAT · Traditional | Leone S.P.A. | 06/19/2025SE |
| K231502 | Mini ScrewsOAT · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 09/04/2024SE |
| K231913 | T-FitOAT · Traditional | Techwin Co., Ltd. | 02/08/2024SE |
| K222245 | ACR Screw SystemOAT · Traditional | Biomaterials Korea, Inc. | 08/21/2023SE |
| K202163 | Mico One Orthodontic ScrewOAT · Traditional | Ze Fang Technology Co., Ltd. | 10/07/2022SE |
| K202691 | Ortholock Anchorage DevicesOAT · Traditional | Craniofacial Technologies, Inc. | 04/28/2022SE |
| K210559 | ATOZ Mini-ScrewOAT · Traditional | Mk Meditech, Inc. | 12/19/2021SE |
| K211992 | Ortho MI SystemOAT · Traditional | Osteonic Co., Ltd. | 10/15/2021SE |
| K202790 | Syntec Orthodontic Mini Screw Extended SystemOAT · Special | Syntec Scientific Corporation | 09/17/2021SE |
More from Syntec Scientific Corporation
Questions and answers
When was HDC Sterile Self Ligating Spider Screw, Model SLI,SL2 cleared by the FDA?
HDC Sterile Self Ligating Spider Screw, Model SLI,SL2 (K091390) received a 510(k) decision of Substantially Equivalent on July 30, 2009, 80 days after the submission was received.
What is the product code of K091390?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.