Scalloped Endopore Endosseous Dental Implant System
510(k) K043190
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043190 | Date14 Dec 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- Withdrawn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
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Scalloped Endopore Endosseous Dental Implant System is an endosseous dental implant designed for surgical placement in the bone of the upper or lower jaw arches. It provides structural support for prosthetic dental devices, such as artificial teeth, to restore chewing function and oral function. The system features a scalloped coronal margin and a 1.5 mm lightly acid-etched region apical to a smooth coronal region, enhancing integration with surrounding bone tissue.
This implant system is intended for single-use in controlled surgical environments and is manufactured from titanium or titanium alloy. It is supplied in sterile packaging and is classified as a Class II medical device under FDA regulations, with clearance via a 510(k) submission (K043190). The system is available in specific diameters and lengths, as referenced in predicate device authorizations, and adheres to FDA standards for dental implants.
Other devices from Innova Life Sciences Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of prosthetic dental devices can the Scalloped Endopore Endosseous Dental Implant System support?
This implant system is designed to provide structural support for prosthetic dental devices such as artificial teeth, helping to restore chewing and oral function. It is specifically intended for surgical placement in the bone of the upper or lower jaw arches to anchor these prosthetics securely.
Is the Scalloped Endopore Endosseous Dental Implant System intended for reuse in clinical settings?
No, the system is explicitly manufactured for single-use in controlled surgical environments. This ensures patient safety and sterility, as it is supplied in sterile packaging and not designed for repeated use.
What materials are used in the construction of the Scalloped Endopore Endosseous Dental Implant System?
The implant system is made from titanium or titanium alloy, materials commonly used in dental implants for their biocompatibility and strength. The design includes a scalloped coronal margin and a lightly acid-etched region to improve bone integration.
How is the Scalloped Endopore Endosseous Dental Implant System packaged, and what does this imply for its use?
The system is supplied in sterile packaging, which means it is ready for immediate surgical use without additional sterilization. This packaging ensures the implant remains uncontaminated until deployment, adhering to best practices for single-use medical devices.
What regulatory pathway was followed for FDA clearance of this implant system?
The Scalloped Endopore Endosseous Dental Implant System received FDA clearance via a 510(k) submission (K043190), classified as a Class II medical device under FDA regulations. The clearance was granted through the Dental (DE) Advisory Committee and was determined to be substantially equivalent to predicate devices, following a special review process.