Manufacturer registered with FDA
Sky HKMC International Limited
HONG KONG, Hong Kong SAR China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
Devices listed with FDA
What Sky HKMC International Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Gold Denture TeethELN · Class 1 | — | Maker | Base Metal, Restoration, Noble Metal, RestorationPorcelain,Restoration,Porcelain-Fused-To-Metal: Restoration, ResinRestoration,Resin-ACCESSORIES,IMPLANT, DENTAL,ENDOSSEoUS: Dentures.Full:Dentures,Partial: Restoration, | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Aocessongs implant dentat, andosscous | 2025 |
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 |
|---|---|---|
| SKY HKMC INTERNATIONAL LIMITEDFDA reg. 3038290056 | HONG KONG, Hong Kong SAR China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093299). 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.