Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024788684

FEI Number

3024788684

Entity Name

Pro-Dex Inc

City/State/Country

Tustin, CA, US

Establishment Address

14401 Franklin Ave, Tustin, CA 92780, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRO-DEX, INC. (Owner Number: 2081135)

Owner / Operator Contact Address

2361 McGaw Avenue, --, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro-Dex Surgical Driver (PDSD-5000-X) PDCMF Driver (PDCMF-1000-X) Atlas Pro Driver Hex Collet (APD-CA-001-1) Atlas Pro Driver (APD-1000-1) Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1) Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBP-040-X) Dynatip P/N 3293 Tip, Cover / Protector Atlas Pro Driver (APD-1000-1) Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1) Atlas Pro Driver Hex Collet (APD-CA-001-1)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-03-28
GXL	Screwdriver, Skullplate	Neurology	Class 1	882.4900	2013-03-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-03-07
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2021-12-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-03-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2020-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRO-DEX, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2081135	PRO-DEX, INC.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024788684. Last updated year: 2026. Please use registration number 3024788684 when referencing this establishment in official correspondence.