FDA product code · Dental · Class 2
JEY: Plate, Bone
JEY is FDA's product code for "Plate, Bone": a Class 2 device classified under 21 CFR 872.4760, reviewed by the Dental panel. FDA flags it as an implant.
510(k) review time for JEY
Across 40 510(k) clearances under JEY decided from 2018-01-01 to 2026-10-06, the median was 215 days from FDA receipt to decision. Half took between 132 and 278 days, and 80% were decided within 291 days. These are past clearances, not a forecast for a new submission.
| Fastest | 59 |
|---|---|
| 25th percentile | 132 |
| Median | 215 |
| 75th percentile | 278 |
| 80th percentile | 291 |
| 90th percentile | 434 |
| Slowest | 670 |
| Year | Median days | n |
|---|---|---|
| 2018 | 255 | 7 |
| 2019 | 163 | 6 |
| 2020 | 198 | 6 |
| 2022 | 135 | 5 |
| 2024 | 159 | 5 |
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.
JEY in the public FDA record
| 510(k) clearances, all years | 294 |
|---|---|
| Device recalls | 111 |
| Establishment listings | 532 |
| GUDID device identifiers | 13,822 |
Counts of records, not of devices or events. Adverse event reports for JEY 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 JEY
13 FDA recognized consensus standards cite JEY, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 5832-4 Third edition 2014-09-15; ISO 5832-11 Second edition 2014-09-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 8-405 ISO 5832-4 Third edition 2014-09-15 — Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
- 8-406 ISO 5832-11 Second edition 2014-09-15 — Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- 8-435 ISO 5832-1 Fifth edition 2016-07-15 — Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
- 8-465 ISO 5832-2 Fourth edition 2018-03 — Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
- 8-492 ISO 5832-9 Third edition 2019-02 — Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
- 8-500 ISO 5832-12 Third edition 2019-02 — Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
- 8-587 ISO 5832-3 Fifth Edition 2021-11 — Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- 8-594 ISO 5832-6 Third Edition 2022-03 — Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
- 8-595 ISO 5832-5 Fourth Edition 2022-03 — Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
- 8-619 ISO 5832-4 Fourth edition 2024-04 — Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
- 8-620 ISO 5832-11 Third edition 2024-03 — Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- 8-621 ISO 5832-1 Sixth edition 2024-04 — Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.