Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Keystone Dental and its 1 subsidiaries with 42 510(k) clearances and 16 device recalls. The most recent is a 510(k) clearance dated Jul 9, 2024: Prima Plus Conical Implant System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Keystone Dental and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 9, 2024 | Prima Plus Conical Implant SystemK240966 · DZE | 510(k) clearances |
| May 25, 2023 | Genesis ACTIVE Implant SystemK223814 · DZE | 510(k) clearances |
| Aug 10, 2022 | KDG AbutmentsK221381 · NHA | 510(k) clearances |
| Aug 18, 2020 | Keystone Dental XL Dental Implant SystemK201334 · DZE | 510(k) clearances |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificiClass II · Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it diffi | Device recalls |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as arClass II · Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it diffi | Device recalls |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102Class II · Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it diffi | Device recalls |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101Class II · Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it diffi | Device recalls |
| May 1, 2018 | Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous maClass II · The implants are mislabeled. | Device recalls |
| Mar 13, 2018 | Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an eClass II · The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the | Device recalls |
| Jan 24, 2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillaClass II · The cutting edge of tissue punches may be potentially damaged with small dents and nicks. | Device recalls |
| Oct 16, 2017 | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1KClass III · A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final | Device recalls |
| Oct 28, 2010 | GENESIS IMPLANT SYSTEMK101545 · DZE | 510(k) clearances |
| Jun 5, 2009 | XPI ANGLED ABUTMENTSK090397 · NHA | 510(k) clearances |
| Nov 16, 2007 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSK073032 · NHA | 510(k) clearances |
| Nov 9, 2007 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEMK072241 · NHA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
