Interpore IMZ Single Tooth Attachment System
by Interpore Intl. 510(k)
Active
510(k) K900793
Overview
The Interpore IMZ Single Tooth Attachment System is a dental implant designed for securing single-tooth prostheses. It provides a mechanical attachment mechanism for crowns or bridges, ensuring stable fixation in the oral cavity while mimicking natural tooth function.
This system is intended for use in dental offices by trained professionals, supplied as a sterile, single-use or reusable component depending on the attachment components. It is classified under FDA product code DZE and was granted 510(k) clearance in 1990 for dental applications, with a decision of Substantially Equivalent. No additional regulatory status beyond the stated FDA clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900793 | Date27 Jul 1990 | 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- Withdrawn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 Interpore Intl.
Questions
What types of dental prostheses can the Interpore IMZ Single Tooth Attachment System secure, and how does it ensure stability in the mouth?
The Interpore IMZ Single Tooth Attachment System is designed to secure single-tooth crowns or bridges, providing a mechanical attachment mechanism for stable fixation in the oral cavity. Its purpose is to mimic natural tooth function by ensuring the prosthesis remains securely in place during chewing and daily use, reducing the risk of loosening or displacement.
Is the Interpore IMZ Single Tooth Attachment System intended for single-use or reusable applications, and how should it be handled?
The system is supplied with sterile components, but whether they are single-use or reusable depends on the specific attachment parts involved. The manufacturer recommends following their guidelines for sterilization and reuse protocols to maintain safety and performance. Since it is intended for use in dental offices by trained professionals, proper handling and sterilization procedures should be strictly adhered to.
What was the regulatory pathway for FDA clearance of the Interpore IMZ Single Tooth Attachment System, and when was it approved?
The Interpore IMZ Single Tooth Attachment System received FDA 510(k) clearance under the Traditional pathway in 1990, with a decision of *Substantially Equivalent* to a predicate device. The clearance was granted under product code DZE, which categorizes it for dental applications, and was reviewed by the Dental (DE) Advisory Committee.
How does the Interpore IMZ Single Tooth Attachment System differ from other dental implant systems in terms of its intended use?
Unlike some dental implant systems that focus on osseointegration (direct bone attachment), the Interpore IMZ Single Tooth Attachment System specifically provides a mechanical attachment mechanism for securing single-tooth prostheses—such as crowns or bridges—without requiring full implant integration into the jawbone. This makes it ideal for cases where a stable but removable or semi-permanent solution is preferred.