# K982925: Laminoss Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Impladent, Ltd.
- Decided: May 18, 1999 after 271 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033392: Immediate Stabilizing Implant (Isi) (2003), 5 descendants of its own
- K090174: Tsi; Eri (2009), 4 descendants of its own
- K083544: Kat Implant System (2009), 4 descendants of its own
- K101201: Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model: 002061, 002062, 002063, 002064, (2011), 3 descendants of its own
- K122664: Zuga Dental Implant System (2013), 1 descendant of its own

## Indications for use
The LAMINOSS® Osteocompressive Implant System consists of a one-piece and two-piece immediately-loaded screw implants for the maxillary and mandibular arches to support fixed or removable prostheses.

Source page: https://510kreport.com/device/K982925
Methodology: https://510kreport.com/methodology