Manufacturer registered with FDA
EMERY ENTERPRISES INC.dba ITL Dental
Irvine, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 499 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name EMERY ENTERPRISES INC.dba ITL Dental 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 | EMERY ENTERPRISES INC.dba ITL Dental | 2 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | EMERY ENTERPRISES Inc. DBA ITL DENTALEMERY ENTERPRISES INC. dba ITL DENTAL | 49 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | EMERY ENTERPRISES, INC DBA ITL DENTAL | 48 | 2020–2021 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Emery Enterprises Inc. Dba ITL Dental | 2 | — | 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 EMERY ENTERPRISES INC.dba ITL Dental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PRECISE | 2006 |
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
EMERY ENTERPRISES INC.dba ITL Dental 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: The Implant Center of the Palm Beaches (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Mar 1996 | K960110 | KIS MT3 | The Implant Center of the Palm Beaches | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EMERY ENTERPRISES INC.FDA reg. 2086964 | IRVINE, CA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Emery Enterprises Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9094606). 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.