Registered with FDA
DigiSmiles Lab
Philipsburg, PA, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What DigiSmiles Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | Retainer Screw Expansion Orthodontic | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | temporary crown | 2025 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Alloy, Metal, Base | 2025 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Lister | Alloy, Other Noble Metal | 2025 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Lister | Alloy, Gold-based Noble Metal | 2025 |
| Wire ClaspEJW · Class 1 | — | Lister | Clasp Wire | 2025 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | Teeth, Artificial, POSTERIOR with Metal Insert | 2025 |
| Preformed CrownELZ · Class 1 | — | Lister | Crown Preformed | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DigiSmiles Lab lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: 3M Company (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jan 1994 | K935041 | 3M TEMPORARY CROWN & BRIDGE MATERIAL | 3M Company | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIGISMILES LABFDA reg. 3035335007 | Philipsburg, PA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092397). 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.