# K112046: Mta Angelus

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Productos Odontologicos
- Decided: Jan 6, 2012 after 172 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011009 (2001). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073218: Mta Advanced Material, Dentsply Interntional (2008) Summary page 2.
- K011009: White Mta Material, Dentsply International (2001) Summary page 2.
- K080203: Mta Root Canal Sealer, Dentsply Interntional (2008) Summary page 2.

## Most influential descendants
- K113568: Mta-Fillapex (2012), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K201799: CleaniCal (2021), 2 descendants of its own
- K151047: MTA Repair HP (2016), 2 descendants of its own
- K140247: Mta Fillapex (2014), 2 descendants of its own

## Indications for use
Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions Via canal treatment of root perforation due to internal resorption Surgical treatment of root perforation due to internal resorption Periapical surgery with reverse filling Pulp capping Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue) Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp) Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)

Source page: https://510kreport.com/device/K112046
Methodology: https://510kreport.com/methodology