Manufacturer registered with FDA
Shenzhen Perfect Medical Instruments Co., Ltd.
Shenzhen, China. Lists 9 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 12023–2023
- Markets registered in
- 631 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Shenzhen Perfect Medical Instruments 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 | Shenzhen Perfect Medical Instruments Co., Ltd. | 1 clearances | 2023–2023 | Below |
| Brazil | ANVISA | Manufacturer | SHENZHEN PERFECT MEDICAL INSTRUMENTS CO. LTD.SHENZHEN PERFECT MEDICAL INSTRUMENTS CO | 14 | 2013–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD. | 9 | 2023–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shenzhen Perfect Medical Instruments Co., Ltd.Shenzhen Perfect Medical Instruments Co., Ltd | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.Shenzhen Perfect Medical Instruments Co., Ltd. | 2 | 2022–2025 | 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 Shenzhen Perfect Medical Instruments 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | WIRE, ORTHODONTIC; profa wires | 2012 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Irrigation Needle | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Gutta Percha Cutting Pen | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BUR, DENTAL; profa dental bur | 2012 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points, Injectable Root Canal Sealer | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | FILE, PULP CANAL, ENDODONTIC; profa file | 2012 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo Motor | 2023 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Ultrasonic irrigation activator, Irrigation activator, Wave Tip, Working Tip | 2023 |
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 |
|---|---|---|
| SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.FDA reg. 3009431661 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041190). 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.