KELSEY DENTAL LLC

FDA Device Registration & Listing · The Woodlands, TX, US · Registration 3039641923

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
3039641923
FEI Number
3039641923
Entity Name
KELSEY DENTAL LLC
City/State/Country
The Woodlands, TX, US
Establishment Address
32222 Tamina Rd Ste 5-09a, The Woodlands, TX 77354, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Kelsey Dental LLC (Owner Number: 10093877)
Owner / Operator Contact Address
32222 Tamina Road, STE A5-09, The Woodlands, TX 77354, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Zirconia Teeth and Glaze arylic dentures; E.max crown/bridge; metal framework dentures; Porcelain fused to metal crown/bridges; Valplast; zirconi Prefabricated Crown STRAUMANN DENTAL IMPLANT SYSTEM Denture Material and Adhesive

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSP Restoration, Porcelain Unknown Class N N/A 2025-12-03
ELJ Teeth, Artificial, Posterior With Metal Insert Dental Class 1 872.3900 2025-08-06
ELZ Crown, Preformed Dental Class 1 872.3330 2025-08-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-07-26
NSL Dentures, Full Unknown Class N N/A 2025-12-03

Official Correspondent

Darren Kelsey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kelsey Dental LLC
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

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.

Similar Registrations

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3021389380 ABL DENTAL SOLUTIONS S.A.S Envigado Antioquia, CO
3005310881 DIGITAL DENTAL FUSION KOREA Seoul, KR
3021241833 LEAGUE DENTAL TECHNOLOGY LTD Shenzhen Guangdong, CN
3005952241 ACER DENTALLAB CO LIMITED HONGKONG, HK
3007268434 ADS DENTAL LAB LTD. Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039641923. Last updated year: 2026. Please use registration number 3039641923 when referencing this establishment in official correspondence.
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