Devices

Device Recall PrimaConnex Implant System

Model / Serial
REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution in the states of ND, NJ & MA
Product Description
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K || pRODUCT Usage: || Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Manufacturer
Keystone Dental Inc
1 Event
- Recall of Device Recall PrimaConnex Implant System

Manufacturer

Keystone Dental Inc

Manufacturer Address
Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
Manufacturer Parent Company (2017)
Keystone Dental Inc
Source
USFDA

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