Data / Medical devices / United States / Mountain Dental Lab Service Inc
Mountain Dental Lab Service Inc: FDA-registered device maker in Bothell, WA, United States, 1 510(k) clearance
Mountain Dental Lab Service Inc is registered with the FDA (registration 3033085428) in Bothell, WA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 1980. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033085428
- Address
- 17306 North Rd, Bothell, WA, United States, 98012
- Owner or operator
- Mountain Dental Lab Service Inc (10093108)
- Roles
- Repackager or relabeler
- First device listed
- March 31, 2025
- Registered through
- 2026
- Brand names listed
- DENTSPLY INTL, MOUNTAIN DENTAL SERVICES, SHEN FU ARTS LAB
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 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 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 |
|---|---|---|---|---|---|---|
| March 12, 1980 | K800400 | MAXUM DENTURE RESIN | EBI | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Pin, Retentive And Splinting, And Accessory Instruments
- All makers of Alloy, Gold-Based Noble Metal
- All makers of Alloy, Metal, Base
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Alloy, Other Noble Metal
- All makers of Wax, Dental, Intraoral
Updated March 12, 1980. 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.