FDA product code MDL: Implant, Transmandibular
MDL is the FDA product code for implant, transmandibular. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under MDL, from 2 different applicants. The average 510(k) review took 170 days (median 170).
Classification
| Field | Value |
|---|---|
| Device name | Implant, Transmandibular |
| Device class | Class II |
| Regulation | 21 CFR 872.4760 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MDL clearance
Top MDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interphase Implants, Inc. | 1 | 1990-11-16 |
| Ormco Corp. | 1 | 1985-08-29 |
Most recent MDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900433 | Interphase Implants, Inc. | SMOOTH STAPLE IMPLANT | 1990-11-16 | 290 |
| K852894 | Ormco Corp. | ORMCO TRANSMANDIBULAR IMPLANT | 1985-08-29 | 51 |
Recalls for MDL devices
openFDA lists no recalls for product code MDL.
Frequently asked questions
What is FDA product code MDL?
MDL is the FDA product code for implant, transmandibular. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel.
What device class is MDL?
Class II, regulation 21 CFR 872.4760. Typical premarket route: 510(k).
How long does a 510(k) take for product code MDL?
Across 2 cleared submissions the average was 170 days from receipt to decision (median 170).
Which companies have the most MDL clearances?
Interphase Implants, Inc. (1); Ormco Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MDL
- Run a recall and safety report across every MDL manufacturer
- Watch product code MDL 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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