Manufacturer registered with FDA
Peng Lim Enterprise Co., Ltd.
KAOHSIUNG, Taiwan. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 22006–2006
- Markets registered in
- 39 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Peng Lim Enterprise 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 | Peng Lim Enterprise Co., Ltd. | 2 clearances | 2006–2006 | Below |
| Australia | TGA | Manufacturer | Peng Lim Enterprise Co Ltd | 5 | 2006–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | PENG LIM ENTERPRISE CO., LTDPENG LIM ENTERPRISE CO.,LTD · Peng Lim Enterprise Co., Ltd | 4 | 2005–2015 | 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 Peng Lim Enterprise 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 |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | DENTAL HANDPIECE | 2015 |
| Preformed CrownELZ · Class 1 | — | Maker | KID CROWN | 2006 |
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 Peng Lim Enterprise Co., Ltd. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PENG LIM ENTERPRISE CO., LTD.FDA reg. 8043296 | KAOHSIUNG, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8043296). 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.