Registered with FDA
Primotec LLC
Norwalk, CT, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Primotec 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 | Lister | Primotec LLC | 7 device types | — | Below |
| Canada | Health Canada | Registration holder | PRIMOTEC | 1 | 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 Primotec 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 Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | PREMIOtemp | 2013 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Primotec ZRT | 2016 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | REF-LINE | 2018 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | CLEAR FLEXprimoflex CLEAR | 2020 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | PrimoPink | 2019 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | PREMIOtitan | 2020 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Lister | AGC | 2019 |
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
Primotec 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: Liaoning Upcera Co., Ltd (2), Schutz Dental GmbH (1), Rizhao Huge Dental Industry Co., Ltd. (1), Vipi Industria,Comercio,Exportacao E Importacao DE (1), Huge Dental Material Co., Ltd. (1), Wieland Edelmetalle GmbH & Co. (1), I.T.C. Ent. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Oct 2016 | K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Schutz Dental GmbH | EBF Resin Tooth Shade Material |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 9 Feb 2015 | K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 22 Oct 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 16 Dec 2010 | K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE | EBG Resin Temporary Crown and Bridge |
| 16 Aug 2010 | K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | ELM Teeth Plastic Denture |
| 23 May 2000 | K001041 | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD | Wieland Edelmetalle GmbH & Co. | EJT Gold-Based Noble Metal Alloy |
| 17 Feb 1994 | K926070 | PRIMODENT ACRYLIC TEETH | I.T.C. Ent. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRIMOTEC LLCFDA reg. 3004491043 | Norwalk, CT, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041713). 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.