FDA product code · Dental · Class 2
KIF: Resin, Root Canal Filling
KIF is FDA's product code for "Resin, Root Canal Filling": a Class 2 device classified under 21 CFR 872.3820, reviewed by the Dental panel.
510(k) review time for KIF
Across 58 510(k) clearances under KIF decided from 2018-01-01 to 2026-10-06, the median was 104 days from FDA receipt to decision. Half took between 64 and 186 days, and 80% were decided within 231 days. These are past clearances, not a forecast for a new submission.
| Fastest | 2 |
|---|---|
| 25th percentile | 64 |
| Median | 104 |
| 75th percentile | 186 |
| 80th percentile | 231 |
| 90th percentile | 283 |
| Slowest | 441 |
| Year | Median days | n |
|---|---|---|
| 2018 | 147 | 5 |
| 2019 | 252 | 7 |
| 2021 | 89 | 12 |
| 2023 | 59 | 7 |
| 2024 | 96 | 8 |
| 2025 | 90 | 7 |
| 2026 (to 10-06, partial) | 109 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
KIF in the public FDA record
| 510(k) clearances, all years | 146 |
|---|---|
| Establishment listings | 197 |
| GUDID device identifiers | 434 |
Counts of records, not of devices or events. Adverse event reports for KIF are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite KIF
7 FDA recognized consensus standards cite KIF, among them ISO 6876 Third edition 2012-06-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12; ANSI ADA Standard No. 41-2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-199 ISO 6876 Third edition 2012-06-01 — Dentistry -- Root canal sealing materials
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-309 ISO 6877 Third edition 2021-09 — Dentistry - Endodontic obturating materials
- 4-328 ANSI ADA Standard No. 57-2021 — Endodontic Sealing Materials
- 4-351 ISO 6877 Fourth edition 2025-08 — Dentistry - Endodontic obturating materials
- 4-97 ANSI ADA Standard No. 57-2000 (R2012) — Endodontic Sealing Material
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.