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House Brand Dentistry

FDA UDI

Class II (US FDA UDI)

by Frontier Dental Supply Inc

Identity

Trade Name
House Brand Dentistry FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Earloop 3-PLY Masks 50/Bx ASTM 1 Blue BFE=>95, PFE=>95, Synthetic Blood 80 mmHg FDA UDI
Model / Reference
HSB-109120 FDA UDI
Description
Earloop 3-PLY Masks 50/Bx ASTM 1 Blue BFE=>95, PFE=>95, Synthetic Blood 80 mmHg FDA UDI

Identifiers

Catalog Number
HSB-109111 FDA UDI
Primary DI / UDI-DI
00810132800467 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

House Brand Dentistry by Frontier Dental Supply Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, non-antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8c977e3a-3c72-43b2-bfcb-ee132e56b62b 34 fields · synced May 30, 2026