FDA product code KIF: Resin, Root Canal Filling
KIF is the FDA product code for resin, root canal filling. It is a Class II device, regulated under 21 CFR 872.3820 and reviewed by the Dental panel. FDA has cleared 147 510(k) submissions under KIF, 31 in the last five years, from 72 different applicants. The average 510(k) review took 135 days (median 96); 109 days on average over the last three years. FDA has posted 2 recalls for KIF devices.
Classification
| Field | Value |
|---|---|
| Device name | Resin, Root Canal Filling |
| Device class | Class II |
| Regulation | 21 CFR 872.3820 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KIF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 221 |
| 2018 | 5 | 197 |
| 2019 | 7 | 239 |
| 2020 | 3 | 276 |
| 2021 | 12 | 123 |
| 2022 | 3 | 163 |
| 2023 | 7 | 108 |
| 2024 | 8 | 111 |
| 2025 | 7 | 91 |
| 2026 | 6 | 125 |
Compare with all 510(k) review times · Search every KIF clearance
Top KIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meta Biomed Co., Ltd. | 9 | 2023-09-29 |
| Innovative Bioceramix, Inc. | 8 | 2023-05-31 |
| Maruchi | 7 | 2023-02-14 |
| DiaDent Group International | 6 | 2021-03-25 |
| Ultradent Products, Inc. | 5 | 2021-10-13 |
67 more applicants have KIF clearances. See the full list in Caduvo.
Most recent KIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262050 | Spident Co., Ltd. | Vioseal X | 2026-09-11 | 85 |
| K253909 | NuSmile, Ltd. | NeoPEX Pre-Mixed Obturation Paste | 2026-09-04 | 270 |
| K261514 | Guilin Kevin Peter Technology Co., Ltd. | Calcium Hydroxide Temporary Filling Material (KP-Cal) | 2026-08-25 | 110 |
| K261415 | Guilin Kevin Peter Technology Co., Ltd. | Injectable Root Canal Sealer (KP-Root SP) | 2026-06-29 | 60 |
| K253167 | Mediclus Co., Ltd. | Any-Paste | 2026-01-12 | 108 |
Recalls for KIF devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-31.
Frequently asked questions
What is FDA product code KIF?
KIF is the FDA product code for resin, root canal filling. It is a Class II device, regulated under 21 CFR 872.3820 and reviewed by the Dental panel.
What device class is KIF?
Class II, regulation 21 CFR 872.3820. Typical premarket route: 510(k).
How long does a 510(k) take for product code KIF?
Across 147 cleared submissions the average was 135 days from receipt to decision (median 96).
Which companies have the most KIF clearances?
Meta Biomed Co., Ltd. (9); Innovative Bioceramix, Inc. (8); Maruchi (7); DiaDent Group International (6); Ultradent Products, Inc. (5).
Have KIF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code KIF
- Run a recall and safety report across every KIF manufacturer
- Watch product code KIF 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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