Keystone Dental Inc
FDA Regulatory Profile
Keystone Dental Inc appears in FDA public data with 16 recalls, 8 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1064-2019, Class II) was initiated on February 22, 2019. Its most recent 510(k) clearance was granted on July 9, 2024.
Summary
- Total Recalls
- 16
- 510(k) Clearances
- 8
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1064-2019 | Class II | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | February 22, 2019 |
| Z-1062-2019 | Class II | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative app | February 22, 2019 |
| Z-1061-2019 | Class II | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applicati | February 22, 2019 |
| Z-1063-2019 | Class II | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | February 22, 2019 |
| Z-2162-2018 | Class II | Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for | May 1, 2018 |
| Z-1485-2018 | Class II | Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth l | March 13, 2018 |
| Z-1443-2018 | Class II | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially o | January 24, 2018 |
| Z-1179-2018 | Class III | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K | October 16, 2017 |
| Z-0727-2018 | Class II | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are | August 25, 2017 |
| Z-0608-2018 | Class II | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODU | June 20, 2017 |
| Z-0718-2018 | Class II | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 | June 16, 2017 |
| Z-1818-2017 | Class II | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog | March 9, 2017 |
| Z-0299-2017 | Class II | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code | September 15, 2016 |
| Z-0973-2013 | Class II | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Impla | March 11, 2013 |
| Z-0923-2013 | Class II | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for singl | July 5, 2011 |
| Z-0924-2013 | Class II | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for sin | July 5, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240966 | Prima Plus Conical Implant System | July 9, 2024 |
| K223814 | Genesis ACTIVE Implant System | May 25, 2023 |
| K221381 | KDG Abutments | August 10, 2022 |
| K201334 | Keystone Dental XL Dental Implant System | August 18, 2020 |
| K101545 | GENESIS IMPLANT SYSTEM | October 28, 2010 |
| K090397 | XPI ANGLED ABUTMENTS | June 5, 2009 |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | October 23, 2007 |
| K071599 | EASYGUIDE | July 11, 2007 |