Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219645

FEI Number

1219645

Entity Name

JENSEN INDUSTRIES, INC.

City/State/Country

NORTH HAVEN, CT, US

Establishment Address

50 STILLMAN RD., NORTH HAVEN, CT 06473, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

JENSEN INDUSTRIES, INC. (Owner Number: 1219645)

Owner / Operator Contact Address

50 STILLMAN RD., --, North Haven, CT 06473, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LAVA Frame MiYO Esthetic System MiYO Pink InSync Ceramic System MiYO 850 Lava Esthetic JWE Select J-7 Superior Pulse N3 Platinum Foil 0008 Castell JWG Landmark ECO Platinum Foil 001 1400 Solder Stability Security Blaze JP-5 Superior Plus Advantage Integrity State Solution JP-5 w/ Au

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2011-10-31
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2011-10-31
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-01-26
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	1980-06-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JENSEN INDUSTRIES, INC.

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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219645. Last updated year: 2026. Please use registration number 1219645 when referencing this establishment in official correspondence.