Deltamed GmbH
FRIEDBERG Hesse, DE
DELTAMED GMBH appears in FDA device records in FRIEDBERG Hesse, DE. FDA records list 6 510(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 6 510(k) clearances for Deltamed GmbH between 2011 and 2024. The busiest year on record is 2011, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243720 | 3Delta UNlimited | EBF | Substantially Equivalent | |
| K230341 | ACRIFIX | EBI | Substantially Equivalent | |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | EBI | Substantially Equivalent | |
| K211804 | 3Delta Crown | EBF | Substantially Equivalent | |
| K200039 | P pro Crown & Bridge | EBG | Substantially Equivalent | |
| K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | EBG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002789526 | 3002789526 | DELTAMED GMBH | RAIFFEISENSTR. 8a, FRIEDBERG Hesse D-61169 DE | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- DYTMaintainer, Space Preformed, Orthodontic
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EEAPlate, Base, Shellac
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain