Registered with FDA
Evolve Dental Technologies, Inc.
Irvine, CA, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Evolve Dental Technologies, 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 | Lister | Evolve Dental Technologies, Inc. | 6 device types | — | Below |
| Canada | Health Canada | Registration holder | EVOLVE DENTAL TECHNOLOGIES, INC. | 1 | 2016–2016 | 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 Evolve Dental Technologies, 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 |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | KoR Light Body WashKoR Putty Fast SetKoR Putty Regular Set | 2013 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | KöR Oral Suction Tip | 2013 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | KöR Disposable Impression TraysKöR EVA Sheets | 2013 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | KoR Cheek Retractor | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | KöR Dam | 2013 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | — | 2016 |
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
Evolve Dental Technologies, 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: Crown Delta Corp. (2), Phoenix Dental, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 22 Dec 1998 | K983477 | SUPER SEAL | Phoenix Dental, Inc. | EJK Calcium Hydroxide Cavity Liner |
| 7 Jun 1982 | K821221 | DENTAL IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EVOLVE DENTAL TECHNOLOGIES, INC.FDA reg. 3010407924 | Irvine, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044828). 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.