# K210523: Implanova

- Pathway: 510(k) (Traditional)
- Applicant: Dental Evolutions, Inc.
- Decided: Sep 30, 2021 after 219 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
The Implanova® implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® system including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Short implants (6mm) are intended for delayed loading. All 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. All 3.0mm implants must be splinted if two or more are used adjacent to each other. The 3.0mm implants (except 8mm length) are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 3.0mm implant with 8mm length is intended for delayed loading. Implanova® All-in-One™ implants are indicated to be used when primary stability of the implant allows presence of an abutment at the time of placement. Implanova® All-in-One TM are immediately loaded by the presence of the abutment, but the occlusal forces need to be controlled and restricted while osseointergration takes place. All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures. The Implanova® TiTACH™ system is indicated as a removable attachment of a full arch prosthesis when used in pairs and for a partial arch prosthesis in pairs. Minimum of two attachments are indicated per arch. Indicated to secure a complete or partial denture on 2-6 implants. This prosthesis is removable by patients. The Implanova® FRIDGE® is indicated as a fixed attachment of a full arch prosthesis when used with 6 implants. This prosthesis is fixed for patients and removable by dentists.

Source page: https://510kreport.com/device/K210523
Methodology: https://510kreport.com/methodology