Orthodontic Miniscrew for Absolute Anchorage
FDA 510(k) K130476 · Dental Morelli
510(k) numberK130476
Submission
- Device name
- Orthodontic Miniscrew for Absolute Anchorage
- Applicant
- Dental Morelli
Aventura, FL, US - Received
- February 25, 2013
- Decision date
- January 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 510(k) | Device | Decision |
|---|---|---|
| K131197 | Edgewise Ceramic Brackets, Roth Ceramic BracketsNJM · Traditional | 08/27/2013SE |
Questions and answers
When was Orthodontic Miniscrew for Absolute Anchorage cleared by the FDA?
Orthodontic Miniscrew for Absolute Anchorage (K130476) received a 510(k) decision of Substantially Equivalent on January 8, 2014, 317 days after the submission was received.
What is the product code of K130476?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.