Dental Direkt GmbH
Spenge North Rhine-Westphalia, DE
Dental Direkt GmbH appears in FDA device records in Spenge North Rhine-Westphalia, DE. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Dental Direkt GmbH between 2015 and 2024. The busiest year on record is 2023, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241579 | DD Hybridlayer (multicolored zirconia) | EIH | Substantially Equivalent | |
| K230410 | DD medical polymers (PMMA) | EBI | Substantially Equivalent | |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | NHA | Substantially Equivalent | |
| K191111 | DD Solid Connect® CAD/CAM Abutments | NHA | Substantially Equivalent | |
| K193588 | DD Contrast | EIH | Substantially Equivalent | |
| K183569 | DD cube ONE ML | EIH | Substantially Equivalent | |
| K170885 | DD cubeX2 HS | EIH | Substantially Equivalent | |
| K153490 | DD medical polymers | EBG | Substantially Equivalent | |
| K150196 | DD cubeX2 | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008347275 | 3008347275 | Dental Direkt GmbH | Industriezentrum 106-108, Spenge North Rhine-Westphalia 32139 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EBGCrown And Bridge, Temporary, Resin
- MQCMouthguard, Prescription
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Dental Direkt GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain