The Straumann Ortho Implant System
510(k) K040469
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040469 | Date30 Apr 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OAT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Straumann Ortho Implant System is an endosseous orthodontic implant. It is classified as a Class II dental device.
The device received FDA 510(k) clearance (K040469) on April 30, 2004, and is substantially equivalent to a predicate device. It is manufactured by The Straumann Co. and supplied non-sterile for use in dental orthodontic applications.
Other devices from The Straumann Company
Questions
AI-generated answers, 24 Sep 2026
What is the Straumann Ortho Implant System used for?
The Straumann Ortho Implant System is an endosseous orthodontic implant designed for use in dental orthodontic applications, providing anchorage for tooth movement during orthodontic treatment.
How is the Straumann Ortho Implant System supplied and is it sterile?
The device is supplied non-sterile by The Straumann Co., requiring sterilization by the user prior to implantation in accordance with validated procedures for endosseous dental implants.
What regulatory pathway was used for the Straumann Ortho Implant System?
The device received FDA 510(k) clearance under submission K040469 on April 30, 2004, demonstrating substantial equivalence to a legally marketed predicate device.