Registered with FDA

Mountain Dental Lab Service Inc

Bothell, WA, United States. Lists 7 dental device types with FDA across 1 registered establishment.

FDA owner/operator10093108Repacker / relabeler
Device types listed
7
Brands and models
7
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

What Mountain Dental Lab Service Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethLister
DENTSPLY INTL
2025
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1—Lister
MOUNTAIN DENTAL SERVICES
2025
Intraoral Dental WaxEGD · Class 1—Lister
SHEN FU ARTS LAB
2025
Base Metal AlloyEJH · Class 2Dental alloysLister
MOUNTAIN DENTAL SERVICES
2025
Alloy Other Noble MetalEJS · Class 2Dental alloysLister
SHEN FU ARTS LAB
2025
Gold-Based Noble Metal AlloyEJT · Class 2Dental alloysLister
SHEN FU ARTS LAB
2025
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersLister
SHEN FU ARTS LAB
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

Mountain Dental Lab Service Inc 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: Dentsply Intl., Inc. (1).

Decided510(k)DeviceApplicantDevice type
12 Mar 1980K800400MAXUM DENTURE RESINDentsply Intl., Inc.EBI Rebasing Repairing Relining Denture Resin

Registered establishments

EstablishmentLocationWhat it does
MOUNTAIN DENTAL LAB SERVICE INCFDA reg. 3033085428Bothell, WA, United StatesRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10093108). 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.