Model: 25-2052NG
DI: D771252052NG1
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Dental City Earloop Masks
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c3253000-ff72-4875-982d-63e9f7ba8af0
Distribution Status:
In Commercial Distribution
DUNS Number:
808371371
Device Count:
50
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
D771252052NG0
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D771252052NG1
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 57794
Name: Surgical/medical respirator, non-antimicrobial, single-use
Definition:
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
FDA Product Codes
FXX
Mask, Surgical
Premarket Submissions
Submission Number:
K133070
Supplement Number:
000