Oral Arts Laboratory, Inc.

FDA Device Registration & Listing · Huntsville, AL, US · Registration 3005730680

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
3005730680
FEI Number
3005730680
Entity Name
Oral Arts Laboratory, Inc.
City/State/Country
Huntsville, AL, US
Establishment Address
2700 Memorial Pkwy SW, Huntsville, AL 35801, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Oral Arts Laboratory, Inc. (Owner Number: 10039789)
Owner / Operator Contact Address
2700 S. Memorial Pkwy, Huntsville, AL 35801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EMA EMA 3D Abutment, Implant, Dental, Endosseous, Biodenta Customize Abutment-Hybrid Abutment, Implant, Dental. Endosseous,-Biodenta Customized Abutment-Titanium Abutment, Implant, Dental, Endosseous-Preat Abutments Abutment, Implant, Dental, Endosseous-Preat Abutments QuietNite Abutment, Implant, Dental, Endosseous-Keystone Abutments TAP III

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRK Device, Anti-Snoring Dental Class 2 872.5570 2014-06-20
LRK Device, Anti-Snoring Dental Class 2 872.5570 2025-07-15
LQZ Device, Jaw Repositioning Dental Class 2 872.5570 2025-07-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-11-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-11-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-02-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-02-17
LRK Device, Anti-Snoring Dental Class 2 872.5570 2017-03-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-06-08
LRK Device, Anti-Snoring Dental Class 2 872.5570 2012-02-10

Official Correspondent

Tiffany Marshall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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 3005730680. Last updated year: 2026. Please use registration number 3005730680 when referencing this establishment in official correspondence.
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