Manufacturer registered with FDA
Aceonedent Korea lnd. Co.
Bucheon, South Korea. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Aceonedent Korea lnd. Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | GP Trimmer | 2010 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | ACEONE-ENDO | 1996 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | ACEONE-ENDO | 1996 |
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 |
|---|---|---|
| Aceonedent Korea lnd. Co.FDA reg. 9681748 | BUCHUN-SI Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9026664). 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.