FDA product code · Dental · Class 2
EBG: Crown And Bridge, Temporary, Resin
EBG is FDA's product code for "Crown And Bridge, Temporary, Resin": a Class 2 device classified under 21 CFR 872.3770, reviewed by the Dental panel.
510(k) review time for EBG
Across 43 510(k) clearances under EBG decided from 2018-01-01 to 2026-10-06, the median was 148 days from FDA receipt to decision. Half took between 90 and 223 days, and 80% were decided within 266 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 90 |
| Median | 148 |
| 75th percentile | 223 |
| 80th percentile | 266 |
| 90th percentile | 321 |
| Slowest | 812 |
| Year | Median days | n |
|---|---|---|
| 2019 | 98 | 6 |
| 2020 | 194 | 14 |
| 2024 | 144 | 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.
EBG in the public FDA record
| 510(k) clearances, all years | 189 |
|---|---|
| Establishment listings | 347 |
| GUDID device identifiers | 13,760 |
Counts of records, not of devices or events. Adverse event reports for EBG 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 EBG
5 FDA recognized consensus standards cite EBG, among them ISO 7491 Second edition 2000-09-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 10477 Fourth edition 2020-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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
- 4-302 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.