Syntec Wetali Orthodontic Mini Screws
FDA 510(k) K142001 · Syntec Scientific Corporation - Taipei Office
510(k) numberK142001
Submission
- Device name
- Syntec Wetali Orthodontic Mini Screws
- Applicant
- Syntec Scientific Corporation - Taipei Office
Taipei, TW - Received
- July 23, 2014
- Decision date
- March 18, 2015
- 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 |
Questions and answers
When was Syntec Wetali Orthodontic Mini Screws cleared by the FDA?
Syntec Wetali Orthodontic Mini Screws (K142001) received a 510(k) decision of Substantially Equivalent on March 18, 2015, 238 days after the submission was received.
What is the product code of K142001?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.