# K121824: Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Lascod Spa
- Decided: Aug 23, 2012 after 63 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kromopan 1: named in the summary without a submission number
- (no number) Kromopan 2: named in the summary without a submission number

## Most influential descendants
- K160441: Identic and KromaFaze Alginate Dental Impression Materials (2016), 2 descendants of its own
- K160097: Image Fast Set, Image Regular Set (2016), 1 descendant of its own
- K253501: Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set  - Multi Pack  (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (2025), 0 descendants of its own

## Indications for use
Kromopan type 1 and 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Source page: https://510kreport.com/device/K121824
Methodology: https://510kreport.com/methodology