# K151047: MTA Repair HP

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Productos Odontologicos
- Decided: Aug 31, 2016 after 499 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: 4 generations back to K011009 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112046: Mta Angelus, Angelus Industria DE Productos Odontologicos (2012) Summary page 4.

## Most influential descendants
- K172701: Bio-C Sealer (2018), 1 descendant of its own
- K190537: BIO-C Sealer Ion+ (2019), 0 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 crown portion of the pulp preserving the vitality and function of the remaining radicular portion) 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/K151047
Methodology: https://510kreport.com/methodology