FDA product code · Dental · Class 2
DZE: Implant, Endosseous, Root-Form
DZE is FDA's product code for "Implant, Endosseous, Root-Form": a Class 2 device classified under 21 CFR 872.3640, reviewed by the Dental panel. FDA flags it as an implant.
510(k) review time for DZE
Across 301 510(k) clearances under DZE decided from 2018-01-01 to 2026-10-06, the median was 216 days from FDA receipt to decision. Half took between 143 and 310 days, and 80% were decided within 353 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 143 |
| Median | 216 |
| 75th percentile | 310 |
| 80th percentile | 353 |
| 90th percentile | 422 |
| Slowest | 868 |
| Year | Median days | n |
|---|---|---|
| 2018 | 200 | 41 |
| 2019 | 231 | 31 |
| 2020 | 230 | 41 |
| 2021 | 182 | 34 |
| 2022 | 243 | 34 |
| 2023 | 248 | 35 |
| 2024 | 222 | 40 |
| 2025 | 184 | 31 |
| 2026 (to 10-06, partial) | 207 | 14 |
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.
DZE in the public FDA record
| 510(k) clearances, all years | 1,548 |
|---|---|
| Device recalls | 211 |
| Establishment listings | 2,268 |
| GUDID device identifiers | 42,749 |
Counts of records, not of devices or events. Adverse event reports for DZE 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 DZE
12 FDA recognized consensus standards cite DZE, 1 of them recognized only in part, among them ISO 10993-14 First edition 2001-11-15; ISO 14801 Third edition 2016-11-01; 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.
- 2-170 ISO 10993-14 First edition 2001-11-15 — Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
- 4-259 ISO 14801 Third edition 2016-11-01 (partial recognition) — Dentistry - Implants - Dynamic loading test for endosseous dental implants
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-270 ANSI ADA Technical Report No. 146-2018 — CAD/CAM Abutments in Dentistry
- 4-338 ISO 22683 First edition 2022-05 — Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
- 4-391 ISO 16498 First edition 2013-07 — Dentistry - Minimal dental implant data set for clinical use
- 8-195 ASTM F2024-10 (Reapproved 2016) — Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
- 8-406 ISO 5832-11 Second edition 2014-09-15 — Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- 8-465 ISO 5832-2 Fourth edition 2018-03 — Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
- 8-585 ASTM F1377-21 — Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075 UNS R31537 and UNS R31538)
- 8-587 ISO 5832-3 Fifth Edition 2021-11 — Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- 8-620 ISO 5832-11 Third edition 2024-03 — Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.