GEORGIA HIGH TECH DENTAL LAB INC

FDA Device Registration & Listing · Lawrenceville, GA, US · Registration 3013960655

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
3013960655
FEI Number
3013960655
Entity Name
GEORGIA HIGH TECH DENTAL LAB INC
City/State/Country
Lawrenceville, GA, US
Establishment Address
1760 Spectrum Dr Unit 106, Lawrenceville, GA 30043, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Georgia High Tech Dental Lab Inc (Owner Number: 10080836)
Owner / Operator Contact Address
1760 Spectrum Dr Unit 106, Lawrenceville, GA 30043, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Abutment, implant, dental, endosseous

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 2025-08-25

Official Correspondent

Joo Chun

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Georgia High Tech Dental Lab 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

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

Registration Number Establishment Name Location
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 3013960655. Last updated year: 2026. Please use registration number 3013960655 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.