Data / Medical devices / United States / Digismiles Lab
Digismiles Lab: FDA-registered device maker in Philipsburg, PA, United States, 1 510(k) clearance
Digismiles Lab is registered with the FDA (registration 3035335007) in Philipsburg, PA, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 26, 1994. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3035335007
- Address
- 219 N Second st Suite #200, Philipsburg, PA, United States, 16866
- Owner or operator
- DigiSmiles Lab (10092397)
- Roles
- Repackager or relabeler
- First device listed
- January 2, 2025
- Registered through
- 2027
- Brand names listed
- Alloy, Gold-based Noble Metal, Alloy, Metal, Base, Alloy, Other Noble Metal, Clasp Wire, Crown Preformed, Retainer Screw Expansion Orthodontic, Teeth, Artificial, POSTERIOR with Metal Insert, temporary crown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Clasp, Wire | EJW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 26, 1994 | K935041 | 3M TEMPORARY CROWN & BRIDGE MATERIAL | EBG | Substantially Equivalent | 3M Company | accessdata.fda.gov |
Compare with other makers
- All makers of Crown, Preformed
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Alloy, Other Noble Metal
- All makers of Clasp, Wire
- All makers of Teeth, Artificial, Posterior With Metal Insert
Updated January 26, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.