FDA device listing
ACCLEAN ERGO PROPHY ANGLE LF,AntiSplatr™ Disposable Prophy Angles,AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk…
FDA device listing 1204274082 · Pac-Dent Inc.
Key facts
| Proprietary names | ACCLEAN ERGO PROPHY ANGLE LF,AntiSplatr™ Disposable Prophy Angles,AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct,AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct,AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct,AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup… |
|---|---|
| Owner/operator | Pac-Dent Inc. |
| Owner/operator number | 10056434 |
| Premarket submissions | K030603 |
| Product codes | EGS |
| Device names | EGS - Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | PAC-DENT INC., Suzhou Pac-Dent Technology Co., Ltd |
| Establishment registrations | 2086043, 3004046477 |
| FEI numbers | 3000719964, 3004046477 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database