# K200676: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn Srl
- Decided: Jul 8, 2020 after 114 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924830 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150432: Idodentine Disc, Idodentine Block, Union Dental S.A. (2015) Summary page 5.

## Indications for use
PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area. ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases. PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

Source page: https://510kreport.com/device/K200676
Methodology: https://510kreport.com/methodology