Manufacturer registered with FDA
Simda Co., Ltd.
Busan, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 32023–2025
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Simda 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Lab AnalogScan BodySIMDA Abutment | 2023 |
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 Simda Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Dec 2025 | K252320 | SIMDA Abutments | NHA Endosseous Dental Implant Abutment |
| 26 Oct 2023 | K232271 | SIMDA abutment | NHA Endosseous Dental Implant Abutment |
| 24 May 2023 | K223663 | SIMDA Abutment | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: IDOC Dental Lab (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIMDA CO.,LTD.FDA reg. 3030426160 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089691). 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.