510(k) K260268
- Device
- OrthoEasy Pal; OrthoEasy Pal Long Neck
- Applicant
- Bernhard Förster GmbH (Bernhard Foerster Ltd.)
- 510(k) number
- K260268
- Product code
- OAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-19
- Date received
- 2026-01-28
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stefan Förster
- Address
- Westliche Karl-Friedrich-Strasse 151 Pforzheim DE 75172 75172
FDA Registration Numbers#
- 3008323540
- 3001561923
- 3008261720
- 3009732568
- 9681207
- 3012396434
- 3004203816
- 1032347
- 8043792
- 3011302692
- 3007515069
- 9614404
- 3013034344
- 3011530718
- 3008812560
- 3015272949
- 3022296393
- 3004049923
- 9611458
- 3031886796
- 3007738812
- 1424263
- 3004158247
- 3015440604
- 3008524225
- 3008812251
- 3003394081
- 3005515228
- 3016543896
- 3005562917
- 3017125693
- 3003402534
- 3008559295
- 3018070878
- 9680963
- 3013508670
- 2031093
- 3010407203
- 3006034256
- 3004730002
- 3005914490
- 3012477813
- 3013701115
- 3013689189
- 3043841530
- 3015399803
- 9613348
- 3010596333
- 8044058
- 3034676720
- 2032098
- 3014270297
- 1424785
- 3005728057
Source Documents#
Other 510(k) Records For Product Code OAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025-06-19 |
| K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | 2024-09-04 |
| K231913 | T-FIT | Techwin Co., Ltd. | 2024-02-08 |
| K222245 | ACR Screw System | Biomaterials Korea, Inc. | 2023-08-21 |
| K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | 2022-10-07 |
| K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | 2022-04-28 |
| K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021-12-19 |
| K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021-10-15 |
| K202790 | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation | 2021-09-17 |
| K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. | 2021-01-08 |
| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020-12-17 |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020-08-28 |
| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020-01-17 |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | 2019-11-06 |
| K181142 | Absoanchor Microimplant | Dentos, Inc. | 2019-02-05 |