# K190552: JJ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jj Implants
- Decided: Dec 6, 2019 after 276 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 4.

## Indications for use
JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.

Source page: https://510kreport.com/device/K190552
Methodology: https://510kreport.com/methodology