Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419247

FEI Number

1419247

Entity Name

PRU-DENT MFG., INC.

City/State/Country

SCHAUMBURG, IL, US

Establishment Address

1929 WRIGHT BLVD., SCHAUMBURG, IL 60193, US

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TIM J. PRUSAITIS (Owner Number: 1419247)

Owner / Operator Contact Address

1929 S. WRIGHT BLVD., --, SCHAUMBURG, IL 60193, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PRU-DENT PRU-DENT PRU-DENT PRU-DENT PRU-DENT PRU-DENT Retipping Service PRU-DENT Dental Instruments PRU-DENT MFG., INC. PRU-DENT PRU-DENT PRU-DENT PRU-DENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2016-12-15
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2016-12-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2016-12-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-09-19
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2016-12-15
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2001-12-07
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-12-15
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2016-12-15
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2023-09-19
EKB	Explorer, Operative	Dental	Class 1	872.4565	2016-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TIM J. PRUSAITIS

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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419247. Last updated year: 2026. Please use registration number 1419247 when referencing this establishment in official correspondence.