FDA UDI In Commercial Distribution 🇺🇸 United States

X-Smart® Apex Locator Touch probe

DI: D100B00XSALAC4000 · Model: 1 · FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
X-Smart® Apex Locator Touch probe
Primary DI
D100B00XSALAC4000
Version / Model
1
Catalog Number
B00XSALAC4000
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
6ceeaf83-1a86-4cff-8184-cc7209d36bda

Device Description

A stainless steel accessory for an Apex Locator which is used when an extender is needed in order to provide electrical contact with the endodontic file

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
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 D100B00XSALAC4000