# K011502: Crystal and Crystal-Care Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Crystal-Seal Dental Implants
- Decided: Oct 22, 2001 after 159 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033392: Immediate Stabilizing Implant (Isi) (2003), 5 descendants of its own
- K090174: Tsi; Eri (2009), 4 descendants of its own
- K110337: Universal Maxillary Molar (2012), 1 descendant of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own
- K142846: BBX1, BBX2, BBX1MO, BBX1MC (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K011502
Methodology: https://510kreport.com/methodology