# K252731: Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Promimic AB
- Decided: May 12, 2026 after 257 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
Longest line of descent: 10 generations back to K925765 (1993). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101225: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1, Promimic AB (2011) Summary page 5.

## Indications for use
The Promimic ZrP Surface Dental Implant and Promimic ZrP + HAnano Surface Dental Implant are intended for surgical placement into the bone of upper/lower jaw arches as permanent anchorages for prosthetic devices and to restore chewing function. The Promimic ZrP Surface Dental Implant and Promimic ZrP + HAnano Surface Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic ZrP + HAnano Surface Dental Implants are only to be used with straight abutments, namely the following components from the Ospol Dental Implant System (K070184): Abutment System Name: Ospol Dental Implant System (K070184) – Straight abutments (regular platform). Platform Diameter: Ø4.0 mm (regular platform). Compatible Ospol Components (regular platform only): - Cover Screw (#1014) - Abutment screw (#3000) - Standard abutment, low (#3001) - Standard abutment, high (#3008) - Anatomic abutment, high (#3004) - Anatomic abutment, low (#3005) - Healing abutment, high (#3006) - Healing abutment, low (#3007) Platform Diameter: Ø4.0 mm (regular platform).

Source page: https://510kreport.com/device/K252731
Methodology: https://510kreport.com/methodology