Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000426619

FEI Number

1000426619

Entity Name

ROLAND DGA

City/State/Country

Irvine, CA, US

Establishment Address

15363 Barranca Parkway, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Roland DGA (Owner Number: 10089780)

Owner / Operator Contact Address

15363 Barranca Parkway, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203590

PMA Number

N/A

All Registered Proprietary Names

Perfit FS Dental Zirconia Fully Sintered Block

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-02-12

Official Correspondent

Lisa Aguirre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Roland DGA

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 1000426619. Last updated year: 2026. Please use registration number 1000426619 when referencing this establishment in official correspondence.