Manufacturer registered with FDA
Meticuly Co., Ltd.
Bangkok, Thailand. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 22024–2026
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1Thailand
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Meticuly Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Meticuly Co., Ltd. | 2 clearances | 2024–2026 | Below |
| United Kingdom | MHRA | Manufacturer | Meticuly Company Limited | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Meticuly Co., Ltd. | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Meticuly 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 |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | METICULY Patient-specific titanium maxillofacial mesh implant | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| METICULY CO., LTD.FDA reg. 3027157194 | Bangkok Krung Thep Maha Nakhon, Thailand | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087798). 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.