One Plus Implant System
510(k) K133050
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133050 | Date19 Sep 2014 | 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- Withdrawn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
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The One Plus Implant System is a dental implant device designed for the surgical placement of implants into alveolar or basal bone of the mandible or maxilla. It is intended to support prosthetic devices, such as artificial teeth, in partially edentulous patients to restore mastication. The system includes components for securing implants within bone structures, facilitating long-term stability and integration. It falls under the category of dental implants as defined by regulatory classifications.
This system is supplied as a sterile, single-use device for surgical use in dental settings. It is available in a 3.0mm diameter configuration and is regulated under the FDA 510(k) clearance process, classified under the Dental advisory committee (DE) with a traditional review pathway. The device is intended for use by trained dental professionals in controlled clinical environments. Storage and handling must comply with sterile surgical protocols to ensure patient safety and device efficacy.
Other devices from Osseofuse, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ONE PLUS Implant System used for?
The ONE PLUS Implant System is designed for surgical placement into alveolar or basal bone of the mandible (lower jaw) or maxilla (upper jaw) to support prosthetic devices, such as artificial teeth. It is specifically intended for patients who are partially edentulous (missing some teeth) to restore chewing function and stability. The system integrates with bone over time to provide long-term support for dental prosthetics.
How is the ONE PLUS Implant System supplied and prepared for use?
The ONE PLUS Implant System is supplied as a sterile, single-use device, meaning it is pre-sterilized and intended for one-time surgical use only. This ensures patient safety and maintains device integrity. Clinicians must follow sterile surgical protocols during handling and implantation to preserve sterility and efficacy.
Is the ONE PLUS Implant System reusable, or is it intended for single-use?
The ONE PLUS Implant System is explicitly designed for single-use only. This is a standard practice for dental implants to prevent cross-contamination and ensure patient safety. Reusing the system could compromise sterility and compromise clinical outcomes.
What diameter configuration is available for the ONE PLUS Implant System?
The ONE PLUS Implant System is available in a single diameter configuration of 3.0mm. This size is optimized for placement in specific bone structures of the mandible or maxilla, providing stability for prosthetic support. The system’s design ensures compatibility with common dental implant protocols.
What storage and handling requirements apply to the ONE PLUS Implant System?
The ONE PLUS Implant System must be stored and handled according to sterile surgical protocols to maintain its integrity and ensure patient safety. This includes keeping the device in its original packaging until immediate use, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise sterility or device performance.