OCO Dental Implant (5.0MM Diameter)
by O Co., Inc. 510(k)
Active
510(k) K023336
Overview
The OCO Dental Implant (5.0mm Diameter) is an endosseous dental implant designed for surgical placement within the maxillary or mandibular bone. It functions as a root substitute to anchor prosthetic restorations, facilitating oral rehabilitation and restoring masticatory function. This implant is intended for use in single-tooth or multi-tooth replacement scenarios, providing a stable foundation for crowns, bridges, or dentures. Its design adheres to dental implant standards for osseointegration, ensuring long-term stability and integration with surrounding bone tissue.
The device is supplied sterile and intended for single-use, requiring surgical placement by a trained dental professional. It is classified as a Class II medical device under FDA regulations and holds a Special 510(k) clearance (K023336) for dental applications. The implant is manufactured by O Co., Inc. and must be stored in accordance with sterile packaging instructions until use. No additional regulatory markings beyond the FDA clearance are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023336 | Date9 Oct 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from O Co., Inc.
Questions
What is the OCO 5.0mm Dental Implant used for?
The OCO 5.0mm Dental Implant is an endosseous implant designed to replace missing teeth by serving as a root substitute. It anchors prosthetic restorations such as crowns, bridges, or dentures, enabling oral rehabilitation and restoring chewing function. Its diameter of 5.0mm is optimized for stable placement in the maxillary or mandibular bone, ensuring long-term integration with surrounding bone tissue through osseointegration.
How is the OCO 5.0mm Dental Implant supplied and prepared for use?
The OCO 5.0mm Dental Implant is supplied sterile in its packaging, ensuring readiness for immediate surgical use. It is intended for single-use only, meaning each implant is designed for one patient procedure. Before use, the implant must be handled in accordance with sterile techniques, and the packaging instructions must be followed to maintain sterility until placement by a trained dental professional.
Is the OCO 5.0mm Dental Implant reusable or single-use?
The OCO 5.0mm Dental Implant is explicitly intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for surgical implants. Reuse is not recommended or supported by the manufacturer.
How should the OCO 5.0mm Dental Implant be stored?
The OCO 5.0mm Dental Implant must be stored strictly according to the sterile packaging instructions provided by O Co., Inc. This includes keeping the implant in its original, unopened packaging until ready for use. Proper storage conditions help preserve sterility and integrity, ensuring the implant remains suitable for surgical placement when needed.
What regulatory clearance does the OCO 5.0mm Dental Implant hold?
The OCO 5.0mm Dental Implant holds a Special 510(k) clearance (K023336) from the FDA for dental applications. This clearance confirms that the device meets FDA standards for safety and effectiveness as a Class II medical device, specifically for use as an endosseous dental implant in single-tooth or multi-tooth replacement scenarios.