Manufacturer registered with FDA
Denovo Dental Inc
Baldwin Park, CA, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 56
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5193 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Denovo Dental 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 | Denovo Dental Inc | 7 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Denovo Dental Inc. | 189 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Denovo Dental Inc | 2 | 2021–2021 | Pure Global AI |
| Canada | Health Canada | Registration holder | DENOVO DENTAL INC. | 1 | 2000–2000 | Pure Global AI |
| Israel | AMAR | Manufacturer | DENOVO Dental Inc. | 1 | — | 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 Denovo Dental 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 | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| Preformed CrownELZ · Class 1 | — | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | D071514D071515D071516D071517D071518D071519D071520D071521 | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENOVO DENTAL INCFDA reg. 2032006 | Baldwin Park, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028620). 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.