Manufacturer registered with FDA
Tim J. Prusaitis
SCHAUMBURG, IL, United States. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Tim J. Prusaitis currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2023 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | PRU-DENT | 2016 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | PRU-DENT | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | PRU-DENT Dental InstrumentsPRU-DENT MFG., INC.PRU-DENT Retipping Service | 2001 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | PRU-DENT | 2016 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | PRU-DENT | 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 |
|---|---|---|
| PRU-DENT MFG., INC.FDA reg. 1419247 | SCHAUMBURG, IL, United States | Contract manufacturer, Manufacturer, Remanufacturer, Repacker / relabeler |
Other names on FDA records
Pru-Dent MFG., Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1419247). 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.