Data / Medical devices / China / Shenzhen Perfect Medical Instruments Co., Ltd.
Shenzhen Perfect Medical Instruments Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Perfect Medical Instruments Co., Ltd. is registered with the FDA (registration 3009431661) in Shenzhen Guangdong, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 26, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009431661
- Address
- Room 103, Building 3, No. 2, Weiqun Road, 4th Community, Henggang Street, Longgang District, Shenzhen Guangdong, China, 518115
- Owner or operator
- Shenzhen Perfect Medical Instruments Co., Ltd. (10041190)
- Roles
- Manufacturer
- First device listed
- June 28, 2012
- Registered through
- 2027
- Brand names listed
- Absorbent Paper Points, BUR, DENTAL; profa dental bur, Endo Motor, FILE, PULP CANAL, ENDODONTIC; profa file, Gutta Percha Cutting Pen, Gutta Percha Points, Injectable Root Canal Sealer, Irrigation Needle, Ultrasonic irrigation activator, Irrigation activator, Wave Tip, Working Tip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 26, 2023 | K222548 | Endo Motor | EKX | Substantially Equivalent | Shenzhen Perfect Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bur, Dental
- All makers of Point, Paper, Endodontic
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Locator, Root Apex
- All makers of Needle, Dental
- All makers of Pick, Massaging
Updated April 26, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.