# K161281: Dentalis Bio Solution Implants

- Pathway: 510(k) (Traditional)
- Applicant: Dentalis Bio Solution Implants, LLC
- Decided: Jan 11, 2017 after 250 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Dentalis Bio Solutions Implant System is used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The Dentalis Bio Solution implant with Narrow diameter Ø3.0 shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors situations. Dentalis Bio Solution One Piece implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations

Source page: https://510kreport.com/device/K161281
Methodology: https://510kreport.com/methodology