# K123276: MM-Seal

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Mega Societe Anonyme
- Decided: Mar 10, 2014 after 507 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 K960548 (1996). 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)
- K042769: Adseal Root Canal Sealer, Meta Biomed Co., Ltd. (2004) Summary page 2.

## Indications for use
The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments. MM-SEAL is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K123276
Methodology: https://510kreport.com/methodology