FDA product code · Dental · Class 2
EBI: Resin, Denture, Relining, Repairing, Rebasing
EBI is FDA's product code for "Resin, Denture, Relining, Repairing, Rebasing": a Class 2 device classified under 21 CFR 872.3760, reviewed by the Dental panel.
510(k) review time for EBI
Across 68 510(k) clearances under EBI decided from 2018-01-01 to 2026-10-06, the median was 106 days from FDA receipt to decision. Half took between 72 and 163 days, and 80% were decided within 186 days. These are past clearances, not a forecast for a new submission.
| Fastest | 0 |
|---|---|
| 25th percentile | 72 |
| Median | 106 |
| 75th percentile | 163 |
| 80th percentile | 186 |
| 90th percentile | 255 |
| Slowest | 492 |
| Year | Median days | n |
|---|---|---|
| 2018 | 158 | 5 |
| 2020 | 283 | 6 |
| 2022 | 154 | 11 |
| 2023 | 96 | 11 |
| 2024 | 90 | 9 |
| 2025 | 79 | 11 |
| 2026 (to 10-06, partial) | 87 | 7 |
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.
EBI in the public FDA record
| 510(k) clearances, all years | 335 |
|---|---|
| Device recalls | 16 |
| Establishment listings | 407 |
| GUDID device identifiers | 10,783 |
Counts of records, not of devices or events. Adverse event reports for EBI 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 EBI
11 FDA recognized consensus standards cite EBI, among them ANSI ADA Standard No. 17-1983 (R2014); ISO 20795-1 Second edition 2013-03-01; ISO 20795-2 Second edition 2013-03-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-130 ANSI ADA Standard No. 17-1983 (R2014) — Denture Base Temporary Relining Resins
- 4-232 ISO 20795-1 Second edition 2013-03-01 — Dentistry - Base polymers - Part 1: Denture base polymers
- 4-233 ISO 20795-2 Second edition 2013-03-01 — Dentistry - Base polymers - Part 2: Orthodontic base polymers
- 4-241 ISO 7491 Second edition 2000-09-01 — Dental materials - Determination of colour stability
- 4-242 ISO 10139-1 Third edition 2018-03 — Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
- 4-258 ISO 10139-2 Third edition 2016-06-15 — Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-294 ANSI ADA Standard No. 139-2020 — Dental Base Polymers
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-301 ISO 21563 Second edition 2021-08 — Dentistry - Hydrocolloid impression materials
- 4-399 ISO TS 19736 First edition 2017-09 — Dentistry - Bonding test between polymer teeth and denture base materials
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.