NEW IMAGE DENTAL LABORATORY, INC.

FDA Device Registration & Listing · Morrow, GA, US · Registration 3004860162

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
3004860162
FEI Number
3004860162
Entity Name
NEW IMAGE DENTAL LABORATORY, INC.
City/State/Country
Morrow, GA, US
Establishment Address
1395 Southlake Parkway, Morrow, GA 30260, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
New Image Dental Laboratory, Inc. (Owner Number: 10057322)
Owner / Operator Contact Address
1395 Southlake Parkway, Morrow, GA 30260, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Abutment, implant, dental, endosseous, Straumann CARES M-Series CAD/CAM System EMA 3D Abutment, implant, dental, endosseous, Zfx Abutments Abutment, implant, dental, endosseous, DESS Dental Smart Solutions Abutment, implant, dental, endosseous, DESS Dental Smart Solutions Abutment, implant, dental, endosseous, DESS Dental Smart Solutions Abutment, Implant, Dental, Endosseous, HIOSSEN Pre-milled Abutments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-24
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2025-01-24
LRK Device, Anti-Snoring Dental Class 2 872.5570 2026-01-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-16

Official Correspondent

Ilissa Feiler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New Image Dental Laboratory, 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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004860162. Last updated year: 2026. Please use registration number 3004860162 when referencing this establishment in official correspondence.
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