Not currently registered with FDA under this name
Pac-Dent International (Suzhou), Ltd.
Jiangsu Province, China. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12003–2003
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Pac-Dent International (Suzhou), Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Some of these clearances are listed with FDA today by another company: Pac-Dent Inc. (1), SPS/Crosstex International (1), Dentsply Sirona, Inc. (1), AMD Medicom Inc (1), Sybron Dental Specialties (1).
Sources
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 of the most recent filing, which can be a US agent.