JAMESB DENTAL STUDIO

FDA Device Registration & Listing · Dumont, NJ, US · Registration 3034686762

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
3034686762
FEI Number
3034686762
Entity Name
JAMESB DENTAL STUDIO
City/State/Country
Dumont, NJ, US
Establishment Address
75 Armour Pl Ste 203, Dumont, NJ 07628, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
JamesB Dental Studio (Owner Number: 10091985)
Owner / Operator Contact Address
75 Armour Place Suite 203, Dumont, NJ 07628, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

JBDS JBDS Solidex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2024-11-22
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2024-11-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-07

Official Correspondent

Jungmin Bae

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JamesB Dental Studio
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034686762. Last updated year: 2026. Please use registration number 3034686762 when referencing this establishment in official correspondence.
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