NUVO IF Implant System
by JJGC Indústria e Comércio de Materiais Dentários S/A.
510(k) K193234
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193234 | Date18 Jun 2020 | 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- Withdrawn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
- FDA applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NUVO IF Implant System is an endosseous dental implant, designed for osseointegration within the jawbone to support dental prosthetics. It is classified under FDA product code DZE and falls under the regulatory category of Class II devices. This system is intended for use in dental implantology to replace missing teeth by providing a stable foundation for crowns, bridges, or dentures. The implant integrates directly with the bone, offering a durable solution for restoring oral function and aesthetics.
The NUVO IF Implant System is supplied as a single-use, sterile device for surgical placement by trained dental professionals. It is regulated under 21 CFR 872.3640 and holds FDA 510(k) clearance with decision code SESE, indicating substantial equivalence to a predicate device. The system is intended for use in controlled clinical settings, such as dental offices or oral surgery clinics, and requires proper handling and storage as per manufacturer guidelines. No additional regulatory approvals beyond the stated FDA_510K are referenced in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the NUVO IF Implant System used for?
The NUVO IF Implant System is designed for dental implantology to replace missing teeth by providing a stable foundation for crowns, bridges, or dentures. It achieves this through osseointegration, where the implant integrates directly with the jawbone, restoring both oral function and aesthetics. This makes it suitable for patients seeking durable, long-term solutions for tooth loss.
How is the NUVO IF Implant System supplied and prepared for use?
The NUVO IF Implant System is supplied as a single-use, sterile device, ensuring safety and consistency for surgical placement. It is intended exclusively for use by trained dental professionals in controlled clinical settings, such as dental offices or oral surgery clinics. Proper handling and adherence to manufacturer guidelines are critical to maintaining sterility and performance.
Is the NUVO IF Implant System reusable or intended for single-use?
The NUVO IF Implant System is explicitly designed for single-use only. This design choice aligns with regulatory standards for dental implants, ensuring patient safety by preventing cross-contamination and maintaining device integrity. Reuse is not recommended or supported by the manufacturer.
What regulatory approvals does the NUVO IF Implant System hold?
The NUVO IF Implant System holds FDA 510(k) clearance with decision code SESE, indicating substantial equivalence to a predicate device. It is classified under FDA product code DZE and regulated under 21 CFR 872.3640. This clearance confirms its compliance with U.S. safety and effectiveness standards for dental implants, ensuring it meets established regulatory requirements for clinical use.
Where should the NUVO IF Implant System be stored before use?
The NUVO IF Implant System must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping it in its original, sealed packaging in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Proper storage ensures the device remains suitable for single-use surgical procedures.