TBJ INCORPORATED

FDA Device Registration & Listing · Chambersburg, PA, US · Registration 3004582535

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
3004582535
FEI Number
3004582535
Entity Name
TBJ INCORPORATED
City/State/Country
Chambersburg, PA, US
Establishment Address
1671 Orchard Drive, Chambersburg, PA 17201, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
TBJ Incorporated (Owner Number: 10085510)
Owner / Operator Contact Address
1671 Orchard Drive, Chambersburg, PA 17201, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surgisonic 1211X Surgisonic Reprocessing Sink Ultrasonic Series

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2022-06-27

Official Correspondent

Todd Campbell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TBJ Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number Establishment Name Location
3008993611 P & T MEDICAL Ningbo Zhejiang, CN
2518690 Keystone Industries - Delran Delran, NJ, US
1000355982 ARMSTRONG MANUFACTURING INCORPORATED Mississauga Ontario, CA
3007697908 Novapharm Research Australia Pty Ltd Rosebery New South Wales, AU
2183301 PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004582535. Last updated year: 2026. Please use registration number 3004582535 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.