Keystone Dental Inc

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
8
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1061-2019Class IIPaltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applicatiFebruary 22, 2019
Z-1063-2019Class IIPaltop 1.25 Hex Drivers, Long Part Number: 60-70101February 22, 2019
Z-1064-2019Class IIPaltop 1.25 Hex Drivers, Short Part Number: 60-70102February 22, 2019
Z-1062-2019Class IIPaltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative appFebruary 22, 2019
Z-2162-2018Class IIPrima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended forMay 1, 2018
Z-1485-2018Class IIGenesis Surgical Cassette Tapered Implants are intended for placement following natural tooth lMarch 13, 2018
Z-1443-2018Class IIStage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially oJanuary 24, 2018
Z-1179-2018Class IIISTAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1KOctober 16, 2017
Z-0727-2018Class IIStage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants areAugust 25, 2017
Z-0608-2018Class IIMulti-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUJune 20, 2017
Z-0718-2018Class IIMax Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 June 16, 2017
Z-1818-2017Class IIKeystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. CatalogMarch 9, 2017
Z-0299-2017Class IIKeystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product codeSeptember 15, 2016
Z-0973-2013Class IIPrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. ImplaMarch 11, 2013
Z-0924-2013Class IIGenesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for sinJuly 5, 2011
Z-0923-2013Class IIGenesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for singlJuly 5, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K240966Prima Plus Conical Implant SystemJuly 9, 2024
K223814Genesis ACTIVE Implant SystemMay 25, 2023
K221381KDG AbutmentsAugust 10, 2022
K201334Keystone Dental XL Dental Implant SystemAugust 18, 2020
K101545GENESIS IMPLANT SYSTEMOctober 28, 2010
K090397XPI ANGLED ABUTMENTSJune 5, 2009
K071070OLYMPUS DENTAL IMPLANT SYSTEMOctober 23, 2007
K071599EASYGUIDEJuly 11, 2007