Tomas Pin
FDA 510(k) K042965 · Dentaurum, Inc.
510(k) numberK042965
Submission
- Device name
- Tomas Pin
- Applicant
- Dentaurum, Inc.
Newtown, PA, US - Received
- October 27, 2004
- Decision date
- April 15, 2005
- 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.
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| 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 |
|---|---|---|
| K062733 | Tomas Pin SD 6, 8, and 10 MMOAT · Traditional | 11/09/2006SE |
| K062732 | Tomas Pin 6 MMOAT · Traditional | 10/25/2006SE |
| K030644 | Contec Duo, Contec LC, Contec LCRDYH · Traditional | 11/21/2003SE |
| K032195 | Dentaurum Glastec Dental Orthodontic CementDYH · Traditional | 10/07/2003SE |
| K030980 | Dentaurum No-Mix One Step Bracket AdhesiveDYH · Traditional | 08/25/2003SE |
| K030977 | Dentaurum Mix Two-Paste Bracket AdhesiveDYH · Traditional | 08/25/2003SE |
| K030641 | Contec LightEBZ · Traditional | 06/10/2003SE |
| K011428 | TriceramEIH · Traditional | 06/05/2001SE |
| K011425 | CarmenEIH · Traditional | 06/05/2001SE |
Questions and answers
When was Tomas Pin cleared by the FDA?
Tomas Pin (K042965) received a 510(k) decision of Substantially Equivalent on April 15, 2005, 170 days after the submission was received.
What is the product code of K042965?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.