CAMLOG Screw Implant System
510(k) K000099
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000099 | Date28 Jan 2000 | 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- Withdrawn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, 23 Sep 2026
The CAMLOG Screw Implant System is a dental implant system designed for use in implantology and restorative dentistry. It serves as a foundation for the placement of dental prosthetics to replace missing teeth.
The system is supplied by Altatec Biotechnologies and is intended for use in clinical settings by qualified dental professionals. The device is regulated under FDA 510(k) clearance with the product code DZE and is classified under the Dental advisory committee.
Other devices from Altatec Biotechnologies
Questions
AI-generated answers, 23 Sep 2026
What is the CAMLOG Screw Implant System used for?
This system is designed for implantology and restorative dentistry, serving as a foundation for placing dental prosthetics to replace missing teeth. It is intended for use in clinical settings by qualified dental professionals.
Who supplies the CAMLOG Screw Implant System?
The system is supplied by Altatec Biotechnologies, a manufacturer based in Potomac, MD, USA. It is distributed through authorized dental supply channels for professional use.
Is the CAMLOG Screw Implant System single-use or reusable?
The device data does not specify whether the system is single-use or reusable. Clinicians should refer to the manufacturer’s instructions for use or contact Altatec Biotechnologies directly for details on reprocessing, sterilization, and reuse protocols.
What sizes and models are available for the CAMLOG system?
The provided device data does not include specific information on available sizes, diameters, lengths, or model variants. For detailed specifications on implant dimensions and compatible components, consult the manufacturer’s product catalog or technical documentation.
How should the CAMLOG Screw Implant System be stored?
Storage requirements are not detailed in the available device data. It is standard practice for dental implant systems to be stored in a dry, cool environment away from direct sunlight and moisture. Verify specific storage conditions with the manufacturer’s labeling or product insert.