Manufacturer registered with FDA

Ashtel Studios, Inc.

Ontario, CA, United States. Lists 15 dental device types with FDA across 1 registered establishment.

FDA owner/operator9094940Specification developer
Device types listed
15
Brands and models
17
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

What Ashtel Studios, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
Dental hand instrument
2021
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
Dental Mirror
2021
Oral Irrigation UnitEFS · Class 1Oral irrigatorsMaker
Soniclean, Water Flosser
2021
Manual ToothbrushEFW · Class 1ToothbrushesMaker
Manual ToothbrushSMART CARESONICLEAN
2015
Intraoral Dental WaxEGD · Class 1—Maker
Brush Buddies, Dental wax
2021
X-Ray Beam AlignerEHA · Class 1—Lister—2008
Polishing Agent StripEHM · Class 1Polishing & prophylaxisMaker
Teeth whitening strips
2023
Preformed Impression TrayEHY · Class 1Impression traysMaker
Dental Guard, Dental Tray
2021
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
Dental probe
2021
Periodontic HoeEMQ · Class 1Dental hand instrumentsMaker
Dental Hoe
2021
Powered ToothbrushJEQ · Class 1ToothbrushesMaker
Soniclean
2019
Dental FlossJES · Class 1Floss & interdental cleanersMaker
Brush Buddies
2019
Tongue ScraperLCN · Class 1—Maker
Brush Buddies, Tongue Cleaner
2021
Sterile Ultraviolet Sanitation/Sterilization (for Toothbrushes) UnitMCF · Class 1—Maker
Soniclean
2019
Battery-Powered Ionic ToothbrushMMD · Class 1ToothbrushesLister
SMART CARESONICLEAN
2008

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

EstablishmentLocationWhat it does
ASHTEL STUDIOS, INC.FDA reg. 3004623350Ontario, CA, United StatesComplaint file establishment, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9094940). 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.