FDA product code · Dental · Class 2
KLE: Agent, Tooth Bonding, Resin
KLE is FDA's product code for "Agent, Tooth Bonding, Resin": a Class 2 device classified under 21 CFR 872.3200, reviewed by the Dental panel.
510(k) review time for KLE
Across 54 510(k) clearances under KLE decided from 2018-01-01 to 2026-10-06, the median was 115 days from FDA receipt to decision. Half took between 88 and 180 days, and 80% were decided within 205 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 88 |
| Median | 115 |
| 75th percentile | 180 |
| 80th percentile | 205 |
| 90th percentile | 273 |
| Slowest | 462 |
| Year | Median days | n |
|---|---|---|
| 2018 | 124 | 8 |
| 2019 | 143 | 6 |
| 2020 | 195 | 6 |
| 2022 | 98 | 8 |
| 2023 | 75 | 6 |
| 2024 | 61 | 7 |
| 2026 (to 10-06, partial) | 87 | 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.
KLE in the public FDA record
| 510(k) clearances, all years | 419 |
|---|---|
| Device recalls | 20 |
| Establishment listings | 600 |
| GUDID device identifiers | 1,638 |
Counts of records, not of devices or events. Adverse event reports for KLE 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 KLE
5 FDA recognized consensus standards cite KLE, among them ISO 29022 First edition 2013-06-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO TS 16506 First edition 2017-07 Corrected version 2018-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-219 ISO 29022 First edition 2013-06-01 — Dentistry - Adhesive - Notched-edge sheer bond strength test
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-324 ISO TS 16506 First edition 2017-07 Corrected version 2018-03 — Dentistry - Polymer-based luting materials containing adhesive components
- 4-348 ISO 9917-1 Third Edition 2025-05 — Dentistry - Water-based cements - Part 1: Acid-base cements
- 4-364 ISO 3990 First edition 2023-07 — Dentistry - Evaluation of antibacterial activity of dental restorative materials luting materials fissure sealants and orthodontic bonding or luting materials
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.