FDA product code · Dental · Class 2
EBZ: Activator, Ultraviolet, For Polymerization
EBZ is FDA's product code for "Activator, Ultraviolet, For Polymerization": a Class 2 device classified under 21 CFR 872.6070, reviewed by the Dental panel.
510(k) review time for EBZ
Across 27 510(k) clearances under EBZ decided from 2018-01-01 to 2026-10-06, the median was 144 days from FDA receipt to decision. Half took between 85 and 252 days, and 80% were decided within 260 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 85 |
| Median | 144 |
| 75th percentile | 252 |
| 80th percentile | 260 |
| 90th percentile | 274 |
| Slowest | 465 |
| Year | Median days | n |
|---|---|---|
| 2019 | 145 | 5 |
| 2020 | 164 | 5 |
| 2022 | 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.
EBZ in the public FDA record
| 510(k) clearances, all years | 214 |
|---|---|
| Establishment listings | 180 |
| GUDID device identifiers | 709 |
Counts of records, not of devices or events. Adverse event reports for EBZ 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 EBZ
5 FDA recognized consensus standards cite EBZ, among them ISO 12609-1 First edition 2013-07-15; ISO 12609-2 First edition 2013-07-15; ISO 12609-1 Second edition 2021-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-282 ISO 12609-1 First edition 2013-07-15 — Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
- 12-283 ISO 12609-2 First edition 2013-07-15 — Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
- 12-378 ISO 12609-1 Second edition 2021-10 — Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
- 4-252 ISO 10650 Second edition 2018-08 — Dentistry - Powered polymerization activators
- 4-262 IEC 80601-2-60 Edition 2.0 2019-06 — Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.