# K230797: SmartMTA Capsule

- Pathway: 510(k) (Traditional)
- Applicant: Sprig Oral Health Technologies, Inc.
- Decided: Mar 24, 2023 after 2 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132825: Retromta-Orthomta II, Biomta (2014) Summary page 5.

## Indications for use
The SmartMTA Capsule is indicated for use as: - Orthograde root canal filling material - Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption. - Repair of root canals as an apical plug during apexification - Root end filling - Pulp capping - Pulpotomy/Partial Pulpotomy

Source page: https://510kreport.com/device/K230797
Methodology: https://510kreport.com/methodology