Manufacturer registered with FDA
Crystalmark Dental Systems, Inc.
Glendale, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Crystalmark Dental Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Crystalmark Dental Systems, Inc. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | CRYSTALMARK DENTAL SYSTEMS, INC. | 1 | 1999–1999 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Crystalmark Dental Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Abrasion Resistant Mirror | 1997 |
| AirbrushKOJ · Class 2 | — | Maker | Crystalair | 2008 |
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
Crystalmark Dental Systems, 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: Crystal Mark, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Dec 1996 | K964145 | ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 | Crystal Mark, Inc. | KOJ Airbrush |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CRYSTALMARK DENTAL SYSTEMS, INC.FDA reg. 2029314 | GLENDALE, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9031606). 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.