Product code EKO
- Device name
- Denture Preformed (Partially Prefabricated Denture)
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3600
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K903672 | DENE BRIDGE | Dirotian Pty. , Ltd. | 1990-12-05 |
| K892255 | DENTAL ROOT ELEVATOR | Zinnanti Surgical Instruments, Inc. | 1989-05-01 |
| K780722 | ADVANCED DENTURE SYSTEM | Advanced Marketing Research Co. | 1978-05-26 |
| K760768 | FLEXIDENT DENTURE | Flexodent Corp. | 1976-10-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D7091032138 | Baltic Denture System BDCreator | Merz Dental GmbH | 2017-11-25 |
| D7091032142 | Baltic Denture System BDKEY PMMA | Merz Dental GmbH | 2017-02-03 |
| D7091032141 | Baltic Denture System BDKEY PMMA | Merz Dental GmbH | 2017-02-03 |
| D7091032140 | Baltic Denture System BDKEY PMMA | Merz Dental GmbH | 2017-02-03 |
| D7091032157 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032153 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032154 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032155 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032156 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032150 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032158 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032159 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032160 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032161 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032162 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032163 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032164 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032152 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032151 | Baltic Denture System BD Load | Merz Dental GmbH | 2016-09-24 |
| D7091032100 | Baltic Denture System BDStarterSet | Merz Dental GmbH | 2016-09-24 |
| D7091032137 | Baltic Denture System BD Key Connect | Merz Dental GmbH | 2016-09-24 |
| D7091032136 | Baltic Denture System BD Key Lock | Merz Dental GmbH | 2016-09-24 |
| D7091032135 | Baltic Denture System BD Key Lock | Merz Dental GmbH | 2016-09-24 |
| D7091032134 | Baltic Denture System BD Key Plane / BD Key Fin | Merz Dental GmbH | 2016-09-24 |
| D7091032133 | Baltic Denture System BD Key | Merz Dental GmbH | 2016-09-24 |
| D7091032132 | Baltic Denture System BD Key | Merz Dental GmbH | 2016-09-24 |
| D7091032131 | Baltic Denture System BD Key | Merz Dental GmbH | 2016-09-24 |
| D7091032120 | Baltic Denture System BD Creator | Merz Dental GmbH | 2016-09-24 |
| D7091032110 | Baltic Denture System BD Key | Merz Dental GmbH | 2016-09-24 |
| D7091032101 | Baltic Denture System BDStarterSet | Merz Dental GmbH | 2016-09-24 |