Manufacturer registered with FDA
Addent, Inc.
Danbury, CT, United States. Lists 9 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 18
- 510(k) clearances
- 72005–2019
- Markets registered in
- 48 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Addent, 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 | Addent, Inc. | 7 clearances | 2005–2019 | Below |
| Australia | TGA | Manufacturer | AdDent Inc | 4 | 2018–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Addent,Inc. | 2 | 2003–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ADDENT, INCADDENT. INC | 2 | 2019–2019 | 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 Addent, 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | TRIMAXVAC-TAK | 2002 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Rite-LiteRite-Lite 2Rite-Lite PRO | 2009 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Calset Aluminum Accessory TraysCalset Composite Warmer | 2009 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Calset Aluminum Accessory TraysCalset Composite Warmer | 2009 |
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | Calset Aluminum Accessory TraysCalset Composite Warmer | 2009 |
| Resin ApplicatorKXR · Class 1 | — | Maker | CoMax | 2009 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | Microlux 2 TransilluminatorMicrolux DW TransilluminatorMicrolux Mini TransilluminatorMicrolux Transilluminator | 2009 |
| Soft Tissue Detector Diagnostic LightNXV · Class 2 | — | Maker | Bio/Screen | 2014 |
| Composite Resin WarmerQGO · Class 1 | — | Maker | Compex HD | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Addent, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Apr 2019 | K182017 | Compex HD | QGO Composite Resin Warmer |
| 24 Jul 2012 | K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | NXV Soft Tissue Detector Diagnostic Light |
| 23 Jan 2009 | K082668 | BIO-SCREEN | NXV Soft Tissue Detector Diagnostic Light |
| 19 Nov 2007 | K072309 | MICROLUX/BLU | EAZ Dental Operating Light |
| 8 Feb 2007 | K062961 | MICROLUX TRANSILLUMINATOR | NTK Light Transmission Caries Detector |
| 23 Jun 2006 | K061395 | CALSET COMPOSITE HEATER | EBZ Ultraviolet Activator for Polymerization |
| 4 Apr 2005 | K041614 | MICROLUX DL | EAZ Dental Operating Light |
Some of these clearances are listed with FDA today by another company: Den-Mat Holdings, LLC (1), Voco GmbH (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ADDENT, INC.FDA reg. 3003694926 | DANBURY, CT, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053384). 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.