FDA product code ELL: Teeth, Porcelain
ELL is the FDA product code for teeth, porcelain. It is a Class II device, regulated under 21 CFR 872.3920 and reviewed by the Dental panel. FDA has cleared 39 510(k) submissions under ELL, 2 in the last five years, from 25 different applicants. The average 510(k) review took 115 days (median 78); 216 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Teeth, Porcelain |
| Device class | Class II |
| Regulation | 21 CFR 872.3920 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ELL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 467 |
| 2024 | 1 | 216 |
Compare with all 510(k) review times · Search every ELL clearance
Top ELL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nobel Biocare AB | 5 | 2016-11-22 |
| Dentsply Intl. | 5 | 1988-05-18 |
| Ivoclar North America, Inc. | 2 | 1994-07-22 |
| Unicep | 2 | 1993-03-16 |
| Jeneric/Pentron, Inc. | 2 | 1991-04-15 |
20 more applicants have ELL clearances. See the full list in Caduvo.
Most recent ELL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240586 | Hangzhou Thales Medtech Co., Ltd. | Additive Manufacturing Zirconia Customized Restoration | 2024-10-03 | 216 |
| K203072 | Franz Biotech, Inc. | Franz Zirconia Dental Crown | 2022-01-19 | 467 |
| K162043 | Nobel Biocare AB | NobelProcera HT ML FCZ Bridge | 2016-11-22 | 120 |
| K153534 | Nobel Biocare AB | NobelProcera HT ML Full Contour Zirconia Crown | 2016-06-06 | 180 |
| K071182 | Nobel Biocare AB | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | 2007-07-11 | 72 |
Recalls for ELL devices
openFDA lists no recalls for product code ELL.
Frequently asked questions
What is FDA product code ELL?
ELL is the FDA product code for teeth, porcelain. It is a Class II device, regulated under 21 CFR 872.3920 and reviewed by the Dental panel.
What device class is ELL?
Class II, regulation 21 CFR 872.3920. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELL?
Across 39 cleared submissions the average was 115 days from receipt to decision (median 78).
Which companies have the most ELL clearances?
Nobel Biocare AB (5); Dentsply Intl. (5); Ivoclar North America, Inc. (2); Unicep (2); Jeneric/Pentron, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ELL
- Run a recall and safety report across every ELL manufacturer
- Watch product code ELL 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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