FDA product code KLE: Agent, Tooth Bonding, Resin
KLE is the FDA product code for agent, tooth bonding, resin. It is a Class II device, regulated under 21 CFR 872.3200 and reviewed by the Dental panel. FDA has cleared 419 510(k) submissions under KLE, 29 in the last five years, from 136 different applicants. The average 510(k) review took 84 days (median 70); 119 days on average over the last three years. FDA has posted 20 recalls for KLE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Tooth Bonding, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KLE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 181 |
| 2018 | 8 | 137 |
| 2019 | 6 | 177 |
| 2020 | 6 | 199 |
| 2021 | 4 | 222 |
| 2022 | 8 | 133 |
| 2023 | 6 | 95 |
| 2024 | 7 | 91 |
| 2025 | 3 | 138 |
| 2026 | 5 | 128 |
Compare with all 510(k) review times · Search every KLE clearance
Top KLE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 20 | 2007-03-14 |
| Ultradent Products, Inc. | 19 | 2024-03-20 |
| Bisco, Inc. | 18 | 2016-09-09 |
| Heraeus Kulzer, Inc. | 16 | 2006-12-01 |
| Kuraray Medical, Inc. | 14 | 2011-10-14 |
131 more applicants have KLE clearances. See the full list in Caduvo.
Most recent KLE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260485 | Mediclus Co., Ltd. | Any-Etch | 2026-05-14 | 90 |
| K260430 | Belport Company, Inc., Gingi-Pak | Porcelain Etch Gel | 2026-04-10 | 59 |
| K252450 | Ivoclar Vivadent, Inc. | Adhese 2 | 2026-03-05 | 213 |
| K260682 | Premier Dental Products Company | Bond-PR Universal Adhesive | 2026-03-03 | 1 |
| K251587 | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | VITA VMLC Primer | 2026-02-23 | 276 |
Recalls for KLE devices
20 product recalls in 11 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2024-11-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code KLE?
KLE is the FDA product code for agent, tooth bonding, resin. It is a Class II device, regulated under 21 CFR 872.3200 and reviewed by the Dental panel.
What device class is KLE?
Class II, regulation 21 CFR 872.3200. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLE?
Across 419 cleared submissions the average was 84 days from receipt to decision (median 70).
Which companies have the most KLE clearances?
Dentsply Intl. (20); Ultradent Products, Inc. (19); Bisco, Inc. (18); Heraeus Kulzer, Inc. (16); Kuraray Medical, Inc. (14).
Have KLE devices been recalled?
Yes: 20 product recalls across 11 recall events; the most recent began 2024-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code KLE
- Run a recall and safety report across every KLE manufacturer
- Watch product code KLE 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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