DIGITAL ARCHES INC.

FDA Device Registration & Listing · Fountain Valley, CA, US · Registration 3035983708

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035983708
FEI Number
3035983708
Entity Name
DIGITAL ARCHES INC.
City/State/Country
Fountain Valley, CA, US
Establishment Address
17197 Newhope St Ste J, Fountain Valley, CA 92708, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Digital Arches Inc. (Owner Number: 10092998)
Owner / Operator Contact Address
17155 Newhope Street, STE H, Fountain Valley, CA 92708, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2025-06-03
EIH Powder, Porcelain Dental Class 2 872.6660 2026-01-09
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2025-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Digital Arches 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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1032227 BRASSELER U.S.A. DENTAL, LLC SAVANNAH, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035983708. Last updated year: 2026. Please use registration number 3035983708 when referencing this establishment in official correspondence.
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