STRAUMANN ORTHOSYSTEM
FDA 510(k) clearance K060062 · decided 2006-02-03
Clearance details
- K-number
- K060062
- Device name
- STRAUMANN ORTHOSYSTEM
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2006-01-09
- Decision date
- 2006-02-03
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- OAT
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Institut Straumann AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268) | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026-05-19 |
| Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944) | Leone S.P.A. | 2025-06-19 |
| Mini Screws (K231502) | Proimtech Saglik Urunleri Anonim Sirketi | 2024-09-04 |
| T-FIT (K231913) | Techwin Co., Ltd. | 2024-02-08 |
| ACR Screw System (K222245) | Biomaterials Korea, Inc. | 2023-08-21 |
| Mico One Orthodontic Screw (K202163) | Ze Fang Technology Co., Ltd. | 2022-10-07 |
| Ortholock Anchorage Devices (K202691) | Craniofacial Technologies, Inc. | 2022-04-28 |
| ATOZ Mini-Screw (K210559) | Mk Meditech, Inc. | 2021-12-19 |
| Ortho MI System (K211992) | Osteonic Co., Ltd. | 2021-10-15 |
| Syntec Orthodontic Mini Screw Extended System (K202790) | Syntec Scientific Corporation | 2021-09-17 |
| OBS Anchorage Screw, Biokey Anchorage Screw (K202278) | Bomei Co, Ltd. | 2021-01-08 |
| Blue Sky Bio TAD (K201919) | Blue Sky Bio, LLC | 2020-12-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, recall (Z-0277-2008) | Straumann USA LLC | 2007-12-04 |
| Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, A recall (Z-0278-2008) | Straumann USA LLC | 2007-12-04 |