Manufacturer registered with FDA
SMD Dental Laboratory
Heungdeok-gu Cheongju-si, South Korea. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What SMD Dental Laboratory 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 | Custom AbutmentCustom Abutments | 2025 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | orthodontic retainer | 2026 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | MAZIC Duro | 2025 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | impression tray | 2026 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | LUXEN Zr, LUXEN Smile | 2025 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, Implant, Dental, Endosseous | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
SMD Dental Laboratory lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Institut Straumann AG (1), DENTALMAX Co., Ltd (1), Dentium USA (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Feb 2025 | K243278 | Custom Abutments | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2018 | K171585 | LUXEN Zr, LUXEN Smile | DENTALMAX Co., Ltd | EIH Porcelain Powder |
| 15 Sep 2016 | K160828 | Dentium Implantium & SuperLine Prosthetics | Dentium USA | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMD DENTAL LABORATORYFDA reg. 3038715999 | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094247). 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.