FDA product code EKO: Denture Preformed (Partially Prefabricated Denture)
EKO is the FDA product code for denture preformed (partially prefabricated denture). It is a Class II device, regulated under 21 CFR 872.3600 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under EKO, from 4 different applicants. The average 510(k) review took 44 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Denture Preformed (Partially Prefabricated Denture) |
| Device class | Class II |
| Regulation | 21 CFR 872.3600 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EKO clearance
Top EKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dirotian Pty. , Ltd. | 1 | 1990-12-05 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-05-01 |
| Advanced Marketing Research Co. | 1 | 1978-05-26 |
| Flexodent Corp. | 1 | 1976-10-15 |
Most recent EKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903672 | Dirotian Pty. , Ltd. | DENE BRIDGE | 1990-12-05 | 113 |
| K892255 | Zinnanti Surgical Instruments, Inc. | DENTAL ROOT ELEVATOR | 1989-05-01 | 27 |
| K780722 | Advanced Marketing Research Co. | ADVANCED DENTURE SYSTEM | 1978-05-26 | 25 |
| K760768 | Flexodent Corp. | FLEXIDENT DENTURE | 1976-10-15 | 11 |
Recalls for EKO devices
openFDA lists no recalls for product code EKO.
Frequently asked questions
What is FDA product code EKO?
EKO is the FDA product code for denture preformed (partially prefabricated denture). It is a Class II device, regulated under 21 CFR 872.3600 and reviewed by the Dental panel.
What device class is EKO?
Class II, regulation 21 CFR 872.3600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKO?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 26).
Which companies have the most EKO clearances?
Dirotian Pty. , Ltd. (1); Zinnanti Surgical Instruments, Inc. (1); Advanced Marketing Research Co. (1); Flexodent Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKO
- Run a recall and safety report across every EKO manufacturer
- Watch product code EKO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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