PrimeLOC Attachment System
by Innovative Product Brands, Inc.
510(k) K220612
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220612 | Date6 Jun 2022 | 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- Withdrawn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, 1 Oct 2026
The PrimeLOC Attachment System is a dental device classified under the product code NHA, designed for use in overdenture attachments. It consists of titanium alloy abutments, retention inserts, and denture housings to provide resilient attachment between dental implants and removable dentures, improving stability and retention in edentulous patients.
This system is supplied as a reusable, non-sterile medical device intended for dental professionals. It is regulated under the FDA’s 510(k) clearance process (K220612) and falls under the Dental advisory committee. The abutments feature a zirconium carbon nitride coating for enhanced durability, biocompatibility, and aesthetic appeal. Storage and handling should comply with dental office protocols for reusable devices.
Other devices from Innovative Product Brands, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PrimeLOC Attachment System used for?
The PrimeLOC Attachment System is designed specifically for overdenture attachments in dental implants. It connects removable dentures to titanium alloy abutments, enhancing stability and retention for edentulous patients. The system’s resilient design ensures a secure fit while reducing discomfort, making it ideal for improving function and confidence in implant-supported dentures.
Is the PrimeLOC Attachment System reusable or single-use?
The PrimeLOC Attachment System is supplied as a reusable device. It is intended for repeated use in clinical settings, provided it adheres to standard dental office protocols for cleaning, sterilization, and maintenance. Reusability helps optimize cost efficiency while maintaining performance and safety.
What materials are used in the PrimeLOC Attachment System, and why?
The system features titanium alloy abutments with a zirconium carbon nitride coating. Titanium alloy provides durability and strength, while the zirconium carbon nitride coating enhances biocompatibility, reduces wear, and improves aesthetics by minimizing metal visibility. This combination ensures long-term reliability and patient comfort.
How should the PrimeLOC Attachment System be stored?
The PrimeLOC Attachment System should be stored in accordance with standard dental office protocols for reusable medical devices. This includes keeping components clean, dry, and protected from contamination or physical damage. Proper storage ensures longevity and maintains the integrity of the zirconium carbon nitride coating.
What regulatory pathway does the PrimeLOC Attachment System follow?
The PrimeLOC Attachment System is regulated under the FDA’s 510(k) clearance process, specifically under product code NHA (Dental Attachments). It was cleared as substantially equivalent (SESE) by the Dental Advisory Committee (DE) on June 6, 2022, with clearance number K220612. This pathway confirms its compliance with FDA standards for dental devices.