FDA product code EFH: Paper, Articulation
EFH is the FDA product code for paper, articulation. It is a Class I device, regulated under 21 CFR 872.6140 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under EFH, from 9 different applicants. The average 510(k) review took 85 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Paper, Articulation |
| Device class | Class I |
| Regulation | 21 CFR 872.6140 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EFH clearance
Top EFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pascal Co., Inc. | 2 | 1992-01-17 |
| Pfingst & Co., Inc. | 1 | 1997-02-10 |
| Prodent Intl., Inc. | 1 | 1987-02-12 |
| Sentek, Inc. | 1 | 1987-02-02 |
| Ardent Intl., Inc. | 1 | 1984-02-21 |
4 more applicants have EFH clearances. See the full list in Caduvo.
Most recent EFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965026 | Pfingst & Co., Inc. | PFINGST PRESSURE PASTE | 1997-02-10 | 55 |
| K912632 | Pascal Co., Inc. | OCCLUDE | 1992-01-17 | 217 |
| K911259 | Pascal Co., Inc. | HYDENT | 1991-06-06 | 76 |
| K864572 | Prodent Intl., Inc. | FIXTECTOR | 1987-02-12 | 84 |
| K870032 | Sentek, Inc. | REVISED T-SCAN SYSTEM | 1987-02-02 | 28 |
Recalls for EFH devices
openFDA lists no recalls for product code EFH.
Frequently asked questions
What is FDA product code EFH?
EFH is the FDA product code for paper, articulation. It is a Class I device, regulated under 21 CFR 872.6140 and reviewed by the Dental panel.
What device class is EFH?
Class I, regulation 21 CFR 872.6140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFH?
Across 10 cleared submissions the average was 85 days from receipt to decision (median 66).
Which companies have the most EFH clearances?
Pascal Co., Inc. (2); Pfingst & Co., Inc. (1); Prodent Intl., Inc. (1); Sentek, Inc. (1); Ardent Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EFH
- Run a recall and safety report across every EFH manufacturer
- Watch product code EFH 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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