Peng Lim Enterprise Co., Ltd.
TaiwanFDA applicant, unverified FDA FEI 3008069117
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Peng Lim Enterprise Co., Ltd. makes
Peng Lim Enterprise Co., Ltd. manufactures dental handpieces, including high-speed air turbine models (Super-Air and Super-QD series) and LED curing lights (LED Prolux 770). These devices are designed for dental procedures, such as drilling and curing composite restorations.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Led Prolux 770 Ref K061695
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3008069117
- Address
- NO.42, WANXING STREET,, KAOHSIUNG
Frequently asked questions
How many devices does Peng Lim Enterprise Co., Ltd. have in the registry?
The registry currently lists 2 devices for Peng Lim Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Peng Lim Enterprise Co., Ltd.'s devices?
Among its 2 most recently registered devices, Peng Lim Enterprise Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Peng Lim Enterprise Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Peng Lim Enterprise Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Peng Lim Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Peng Lim Enterprise Co., Ltd. include HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES and LED PROLUX 770.