Manufacturer registered with FDA
DenQ Co., Ltd.
Busan, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What DenQ Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | DenQ Sub SLA Implant System | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DenQ Accessories | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DenQ Sub SLA Implant System | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DenQ Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Sep 2024 | K240977 | DenQ Sub SLA Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: IDOC Dental Lab (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENQ CO., LTD.FDA reg. 3033524643 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091822). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.