Neodent Implant for Orthodontic Anchorage
FDA 510(k) K102769 · Jjgc Industria E Comercio DE Materiais Dentarios S
510(k) numberK102769
Submission
- Device name
- Neodent Implant for Orthodontic Anchorage
- Applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S
San Diego, CA, US - Received
- September 24, 2010
- Decision date
- February 23, 2011
- 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 |
|---|---|---|
| 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 |
| K103084 | Neodent Graft ScrewDZL · Traditional | 02/14/2011SE |
| K101945 | Neodent Implant SystemDZE · Traditional | 01/26/2011SE |
| K101207 | Neodent Implant SystemDZE · Traditional | 08/02/2010SE |
Questions and answers
When was Neodent Implant for Orthodontic Anchorage cleared by the FDA?
Neodent Implant for Orthodontic Anchorage (K102769) received a 510(k) decision of Substantially Equivalent on February 23, 2011, 152 days after the submission was received.
What is the product code of K102769?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.