FDA UDI In Commercial Distribution 🇺🇸 United States

Propex-Pixi Apex Locator

DI: D100A103000000200 · Model: 1 · FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Propex-Pixi Apex Locator
Primary DI
D100A103000000200
Version / Model
1
Catalog Number
A103000000200
Company Name
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Labeler DUNS
532219235
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-23
Public Version
1
Public Version Date
2026-02-02
Public Version Status
New
Public Device Record Key
f5a617f6-e8bd-47be-8e12-6ca8194b1a3e

Device Description

Propex-Pixi Apex Locator

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LQY Locator, Root Apex

GMDN Terms

Code Name
16355 Endodontic apex locator

Identifiers

Type ID
Primary D100A103000000200

Premarket Submissions

Submission Number Supplement Number
K121206 000