Ortho Implant and Accessories
FDA 510(k) K982509 · Straumann USA
510(k) numberK982509
Submission
- Device name
- Ortho Implant and Accessories
- Applicant
- Straumann USA
Waltham, MA, US - Received
- July 20, 1998
- Decision date
- September 30, 1998
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA)NHA · Traditional | 11/11/2024SE |
| K203753 | Straumann Surgical CassettesKCT · Traditional | 07/29/2021SE |
| K202942 | Straumann 4 mm Short ImplantsDZE · Traditional | 02/08/2021SE |
| K192401 | Straumann Screw-Retained AbutmentsNHA · Traditional | 04/06/2020SE |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional | 06/17/2019SE |
| K171784 | Straumann Dental Implant SystemDZE · Traditional | 01/19/2018SE |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional | 03/08/2017SE |
| K151590 | Straumann RN Gold Abutment for BridgeNHA · Traditional | 03/04/2016SE |
| K151328 | PURE Ceramic ImplantsDZE · Traditional | 01/11/2016SE |
| K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentNHA · Traditional | 09/16/2015SE |
Questions and answers
When was Ortho Implant and Accessories cleared by the FDA?
Ortho Implant and Accessories (K982509) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 72 days after the submission was received.
What is the product code of K982509?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.