Manufacturer registered with FDA
Harvest Dental Products, LLC
Brea, CA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 8
- 510(k) clearances
- 52014–2023
- Markets registered in
- 48 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Harvest Dental Products, LLC 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 | Harvest Dental Products, LLC | 5 clearances | 2014–2023 | Below |
| Canada | Health Canada | Registration holder | HARVEST DENTAL PRODUCTS, LLC | 4 | 2021–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Harvest Dental Products LLC | 2 | 2015–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Harvest Dental Products, LLC | 2 | 2021–2026 | 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 Harvest Dental Products, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | EasyGum Composite Strip | 2024 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Poly CastPolyGumPolySplintTemp EstheticTemp FixZCAD | 2013 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | EasyGum Composite Strip | 2024 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | — | 2024 |
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 Harvest Dental Products, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Aug 2023 | K231389 | Harvest Dental HD Gum Strip | EBI Rebasing Repairing Relining Denture Resin |
| 2 Jun 2023 | K222961 | Harvest Conceal ZR Block Out | EIH Porcelain Powder |
| 12 May 2023 | K222489 | Harvest Printable Resin | EBI Rebasing Repairing Relining Denture Resin |
| 12 Dec 2018 | K180578 | Harvest Dental Polymer Blocks | EBG Resin Temporary Crown and Bridge |
| 21 May 2014 | K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Imagine Milling Technologies, LLC (1), Jensen Industries, Inc. (1).
Also lists devices cleared under other names
Harvest Dental Products, LLC 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: B&D Dental Technologies (1), Vipi Industria,Comercio,Exportacao E Importacao DE (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Aug 2011 | K110719 | ORIGIN ZIRCONIA | B&D Dental Technologies | EIH Porcelain Powder |
| 16 Dec 2010 | K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HARVEST DENTAL PRODUCTS LLCFDA reg. 3008578884 | Brea, CA, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041217). 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.