Data / Medical devices / United States / Addent, Inc.
Addent, Inc.: FDA-registered device maker in Danbury, CT, United States, 4 510(k) clearances
Addent, Inc. is registered with the FDA (registration 3003694926) in Danbury, CT, United States. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003694926
- Address
- 43 Miry Brook Rd, Danbury, CT, United States, 06810
- Owner or operator
- ADDENT, INC. (9053384)
- Roles
- Manufacturer
- First device listed
- October 16, 2002
- Registered through
- 2026
- Brand names listed
- Bio/Screen, Calset Aluminum Accessory Trays, Calset Composite Warmer, CoMax, Compex HD, MICROLUX, MICROLUX 2, MICROLUX DW and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Composite Resin Warmer | QGO | 1 | Manufacturer | accessdata.fda.gov |
| Diagnostic Light, Soft Tissue Detector | NXV | 2 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Light Transmission Caries Detector | NTK | 2 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 1 | Manufacturer | accessdata.fda.gov |
| Warmer, Anesthetic Tube | EFC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2019 | K182017 | Compex HD | QGO | Substantially Equivalent | Addent, Inc. | accessdata.fda.gov |
| January 23, 2009 | K082668 | BIO-SCREEN | NXV | Substantially Equivalent | Addent, Inc. | accessdata.fda.gov |
| February 8, 2007 | K062961 | MICROLUX TRANSILLUMINATOR | NTK | Substantially Equivalent | Addent, Inc. | accessdata.fda.gov |
| June 23, 2006 | K061395 | CALSET COMPOSITE HEATER | EBZ | Substantially Equivalent | Addent, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Operating, Dental
- All makers of Applicator, Resin
- All makers of Light Transmission Caries Detector
- All makers of Transilluminator, Battery-Powered
- All makers of Heat Source For Bleaching Teeth
- All makers of Activator, Ultraviolet, For Polymerization
Updated April 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.