FDA product code · Dental · Class 2
EBF: Material, Tooth Shade, Resin
EBF is FDA's product code for "Material, Tooth Shade, Resin": a Class 2 device classified under 21 CFR 872.3690, reviewed by the Dental panel.
510(k) review time for EBF
Across 136 510(k) clearances under EBF decided from 2018-01-01 to 2026-10-06, the median was 103 days from FDA receipt to decision. Half took between 57 and 194 days, and 80% were decided within 216 days. These are past clearances, not a forecast for a new submission.
| Fastest | 0 |
|---|---|
| 25th percentile | 57 |
| Median | 103 |
| 75th percentile | 194 |
| 80th percentile | 216 |
| 90th percentile | 284 |
| Slowest | 603 |
| Year | Median days | n |
|---|---|---|
| 2018 | 115 | 15 |
| 2019 | 159 | 17 |
| 2020 | 190 | 15 |
| 2021 | 178 | 13 |
| 2022 | 63 | 17 |
| 2023 | 87 | 9 |
| 2024 | 120 | 18 |
| 2025 | 43 | 15 |
| 2026 (to 10-06, partial) | 57 | 17 |
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.
EBF in the public FDA record
| 510(k) clearances, all years | 935 |
|---|---|
| Device recalls | 71 |
| Establishment listings | 1,211 |
| GUDID device identifiers | 20,574 |
Counts of records, not of devices or events. Adverse event reports for EBF 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 EBF
10 FDA recognized consensus standards cite EBF, among them ISO 29022 First edition 2013-06-01; ISO 7491 Second edition 2000-09-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12. 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
- 4-241 ISO 7491 Second edition 2000-09-01 — Dental materials - Determination of colour stability
- 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
- 4-298 ISO 4049 Fifth edition 2019-05 — Dentistry - Polymer-based restorative materials
- 4-302 ISO 10477 Fourth edition 2020-10 — Dentistry - Polymer-based crown and veneering materials
- 4-323 ISO 5139 First edition 2023-05 — Dentistry - Polymer-based composite machinable blanks
- 4-344 ANSI ADA Standard No. 186-2024 — Dentistry - Polymer-based Machinable Blanks
- 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
- 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.