Manufacturer registered with FDA
JamesB Dental Studio
Dumont, NJ, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What JamesB Dental Studio currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | JBDS | 2024 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | JBDS | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Solidex | 2025 |
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 |
|---|---|---|
| JAMESB DENTAL STUDIOFDA reg. 3034686762 | Dumont, NJ, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091985). 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.