# K211225: MIS Ti-base abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jul 28, 2021 after 96 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894844 (1990). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191152: MIS Ti-base Abutment, Dentsply Sirona (2020) Summary page 4.

## Indications for use
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function. Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software. MIS Ti-base abutments are intended for use with the following MIS implants: • C1 conical connection implant system • V3 conical connection implant system • SEVEN internal hex implant system • M4 internal hex implant system • Lance+ internal hex implant system

Source page: https://510kreport.com/device/K211225
Methodology: https://510kreport.com/methodology