Keystone Dental Group
Also known as: Keystone Dental, Inc., Keystone Dental Holdings
A privately held United States implant manufacturer based in Burlington, Massachusetts, whose portfolio includes the Genesis, PrimaConnex and Prima Plus implant systems.
Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.
Key facts
| Headquarters | Burlington, Massachusetts, United States, with manufacturing and distribution in Irvine, CaliforniaVerified spec[1] |
|---|---|
| Country | United StatesVerified spec[1] |
| Founded | Manufacturer documentation not located(No founding date is stated on the company pages we were able to reach) |
| Ownership | Private. Accelmed Growth Partners is a significant investor and its co-founder Uri Geiger chairs the company; Keystone Dental merged with the Israeli manufacturer Paltop Advanced Dental Solutions in 2019Verified spec[1]Described on the company’s own corporate page; we have not confirmed the current shareholding percentages |
| Brand | Keystone Dental, covering the Genesis, PrimaConnex and Prima Plus implant systemsManufacturer-reported[1] |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance7 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K240966 | Prima Plus Conical Implant System | Keystone Dental, Inc. | 2024-07-09 |
| K223814 | Genesis ACTIVE Implant System | Keystone Dental, Inc. | 2023-05-25 |
| K221381 | KDG Abutments | Keystone Dental, Inc. | 2022-08-10 |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental, Inc. | 2020-08-18 |
| K101545 | GENESIS IMPLANT SYSTEM | Keystone Dental | 2010-10-28 |
| K090397 | XPI ANGLED ABUTMENTS | Keystone Dental, Inc. | 2009-06-05 |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | Keystone Dental, Inc. | 2007-10-23 |
Other1 record
Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (96); MR Conditional (4). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.
| Number | Device | Holder | Date |
|---|---|---|---|
| 460 device records | — | Keystone Dental Group | — |
Clearance records for Keystone Dental Group were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Keystone Dental Group.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Company — Keystone Dental Group — Keystone Dental, Inc.. Accessed 2026-07-21.