FDA product code · Dental · Class 2
EIH: Powder, Porcelain
EIH is FDA's product code for "Powder, Porcelain": a Class 2 device classified under 21 CFR 872.6660, reviewed by the Dental panel.
510(k) review time for EIH
Across 140 510(k) clearances under EIH decided from 2018-01-01 to 2026-10-06, the median was 108 days from FDA receipt to decision. Half took between 84 and 174 days, and 80% were decided within 194 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 84 |
| Median | 108 |
| 75th percentile | 174 |
| 80th percentile | 194 |
| 90th percentile | 266 |
| Slowest | 595 |
| Year | Median days | n |
|---|---|---|
| 2018 | 139 | 10 |
| 2019 | 125 | 16 |
| 2020 | 155 | 13 |
| 2021 | 131 | 17 |
| 2022 | 89 | 16 |
| 2023 | 114 | 15 |
| 2024 | 89 | 28 |
| 2025 | 84 | 13 |
| 2026 (to 10-06, partial) | 74 | 12 |
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.
EIH in the public FDA record
| 510(k) clearances, all years | 487 |
|---|---|
| Device recalls | 35 |
| Establishment listings | 587 |
| GUDID device identifiers | 96,947 |
Counts of records, not of devices or events. Adverse event reports for EIH 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 EIH
13 FDA recognized consensus standards cite EIH, among them ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04]; ANSI ADA Standard No. 131-2015 (R2020); 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.
- 4-251 ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] — Dentistry - Ceramic materials
- 4-255 ANSI ADA Standard No. 131-2015 (R2020) — Dental CAD/CAM Machinable Zirconia Blanks
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-263 ISO 9693 Third edition 2019-10 — Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-322 ISO 18675 First edition 2022-05 — Dentistry - Machinable ceramic blanks
- 4-329 ISO 6872 Fifth edition 2024-08 — Dentistry - Ceramic materials
- 4-345 ANSI ADA Standard No. 187-2024 — Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
- 4-370 ANSI ADA Standard No. 126-2015 (R2023) — Casting Investments and Refractory Die Materials
- 4-381 ISO 13078 First edition 2013-02 — Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple
- 4-382 ISO 13078-2 First edition 2016-07 — Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze
- 4-383 ISO 13078-3 First edition 2023-05 — Dentistry - Dental furnace - Part 3: Test method for the evaluation of high temperature sintering furnace measurement with a separate thermocouple
- 4-390 ISO 15912 Second edition 2016-01 — Dentistry - Refractory investment and die material
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.