Envista (Suzhou) Medical Device Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 5 device types.
Envista (Suzhou) Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Aligner, Sequential, Orthodontic Software and 3 other device types. Its earliest product listing with the FDA dates from 1982.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3045923493 |
| FEI number | 3045923493 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Unit D03, D04 of Building 19 and Unit E01 of Building 20 |
| Postal code | 215151 |
| Country | China |
Group
Envista (Suzhou) Medical Device Co., Ltd. is one of 2 plants registered under SYBRON DENTAL SPECIALTIES, INC..
| Plant | City | Device types |
|---|---|---|
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | Class 1 | 1982 | 30 | |
| Aligner, Sequential | Class 2 | Spark Clear Aligner System | 2018 | 14 |
| Maintainer, Space Preformed, Orthodontic | Class 1 | 2023 | 18 | |
| Orthodontic Software | Class 2 | Spark Clear Aligner System | 2021 | 4 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | 2024 | 36 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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