FDA product code · Dental · Class 2
DZI: Drill, Bone, Powered
DZI is FDA's product code for "Drill, Bone, Powered": a Class 2 device classified under 21 CFR 872.4120, reviewed by the Dental panel.
510(k) review time for DZI
Across 12 510(k) clearances under DZI decided from 2018-01-01 to 2026-10-06, the median was 201 days from FDA receipt to decision. Half took between 141 and 293 days, and 80% were decided within 298 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 141 |
| Median | 201 |
| 75th percentile | 293 |
| 80th percentile | 298 |
| 90th percentile | 314 |
| Slowest | 343 |
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.
DZI in the public FDA record
| 510(k) clearances, all years | 50 |
|---|---|
| Device recalls | 20 |
| Establishment listings | 144 |
| GUDID device identifiers | 1,819 |
Counts of records, not of devices or events. Adverse event reports for DZI 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 DZI
5 FDA recognized consensus standards cite DZI, 2 of them recognized only in part, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 1797 Third Edition 2017-05; ISO 10637 Second edition 2018-05. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-281 ISO 1797 Third Edition 2017-05 — Dentistry - Shanks for rotary and oscillating instruments
- 4-305 ISO 10637 Second edition 2018-05 (partial recognition) — Dentistry - Central suction source equipment
- 4-306 ISO 22052 First edition 2020-06 (partial recognition) — Dentistry - Compressed air source equipment
- 4-317 ISO 8325 Third edition 2023-03 — Dentistry - Test methods for rotary instruments
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.