Data / Medical devices / United States / Primotec LLC
Primotec LLC: FDA-registered device maker in Norwalk, CT, United States, 9 510(k) clearances
Primotec LLC is registered with the FDA (registration 3004491043) in Norwalk, CT, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 24, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004491043
- Address
- 215 Westport Ave, Norwalk, CT, United States, 06851
- Owner or operator
- Primotec LLC (10041713)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- March 20, 2013
- Registered through
- 2026
- Brand names listed
- AGC, CLEAR FLEX, PREMIOtemp, PREMIOtitan, PrimoPink, Primosplint, Primotec ZRT, REF-LINE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Complaint file establishment | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Complaint file establishment | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 24, 2016 | K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | EBF | Substantially Equivalent | Schutz Dental GmbH | accessdata.fda.gov |
| December 4, 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| February 9, 2015 | K141421 | PMMA BLOCK | EBG | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
| October 22, 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| December 16, 2010 | K102341 | VIPI BLOCK | EBG | Substantially Equivalent | Vipi Industria,Comercio,Exportacao E Importacao DE | accessdata.fda.gov |
| August 16, 2010 | K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | ELM | Substantially Equivalent | Huge Dental Material Co., Ltd. | accessdata.fda.gov |
| September 17, 2003 | K030832 | PRIMOSPLINT SYSTEM | MQC | Substantially Equivalent | Cosmedent, Inc. | accessdata.fda.gov |
| May 23, 2000 | K001041 | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD | EJT | Substantially Equivalent | Wieland Edelmetalle GmbH & Co. | accessdata.fda.gov |
| February 17, 1994 | K926070 | PRIMODENT ACRYLIC TEETH | ELM | Substantially Equivalent | I.T.C. Ent. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Denture, Plastic, Teeth
- All makers of Material, Tooth Shade, Resin
- All makers of Alloy, Metal, Base
- All makers of Powder, Porcelain
- All makers of Maintainer, Space Preformed, Orthodontic
Updated October 24, 2016. 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.