16 results
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53ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 19, 2017
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
FDA Enforcement
Class III
·Terminated·Keystone Dental Inc·April 4, 2018
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.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·February 21, 2018
Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 25, 2018
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·November 2, 2016
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 20, 2013
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 27, 2013
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 20, 2013
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·May 2, 2018
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 7, 2018
Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for 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.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·March 7, 2018
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·June 20, 2018
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 3, 2019
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 3, 2019
Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 3, 2019
Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·April 3, 2019