Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012481042

FEI Number

3012481042

Entity Name

VULCAN CUSTOM DENTAL

City/State/Country

Hoover, AL, US

Establishment Address

2300 Riverchase Center Suite 825, Hoover, AL 35244, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Vulcan Custom Dental (Owner Number: 10051457)

Owner / Operator Contact Address

2300 Riverchase Center Suite 825, Hoover, AL 35244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Preat Abutments SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment Elos Accurate Custom Ti, Straumann BLX RB/WB Elos Accurate Customized Abutment, Straumann Bone Level, Nobel Replace (3.5), Nobel CC (3, 4.3, 6) Conelog TiBase CAD/CAM Hybrid Elos Accurate CAD/CAM Abutment, Nobel Branemark Altatec TiBase CAD/CAM Hybrid Bridge Camlog TiBase CAD/CAM Hybrid VULCAN-BIOHORIZONS DENTAL IMPLANT ABUTMENTS Preat Abutments BioHorizons CAD/CAM Bars Elos Accurate Custom Ti Abutments iSy TiBase CAD/CAM Hybrid BioHorizons Tapered Pro Conical Dental Implant 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	2023-09-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-08-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-06-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-03-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-09-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-14

Official Correspondent

Brett Muetzel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vulcan Custom Dental

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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3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012481042. Last updated year: 2026. Please use registration number 3012481042 when referencing this establishment in official correspondence.