Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004491043

FEI Number

3004491043

Entity Name

PRIMOTEC LLC

City/State/Country

Norwalk, CT, US

Establishment Address

215 Westport Ave, Norwalk, CT 06851, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Primotec LLC (Owner Number: 10041713)

Owner / Operator Contact Address

360 Westport Ave., Norwalk, CT 06851, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152175

PMA Number

N/A

All Registered Proprietary Names

CLEAR FLEX primoflex CLEAR AGC Primotec ZRT PREMIOtitan Primosplint PrimoPink Primotec ZRT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2018-08-13
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2020-08-19
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2018-01-02
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2019-08-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-01-12
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2020-08-20
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2013-03-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-09-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-07-27

Official Correspondent

Christopher Urist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Primotec LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K915626	Ivoclar North America, Inc.	EZ GOLD	1992-02-25
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3001389926	DENTAL MANUFACTURING SPA	Badia Polesine Rovigo, IT
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004491043. Last updated year: 2026. Please use registration number 3004491043 when referencing this establishment in official correspondence.