Black Bibs

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Black Bibs FDA UDI
Generic Name: Dental bib FDA UDI
Device Name: Black Bibs 17 3/4"x12 7/8" FDA UDI
Model / Reference: 4496 FDA UDI
Description: Black Bibs 17 3/4"x12 7/8" FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784449630 FDA UDI
FDA Product Code: KHR FDA UDI
GMDN Term: Dental bib FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental bib

Black Bibs by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental bib.

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MARK3 — CARGUS INTERNATIONAL, INC · Class II
Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
Patient Armor Barriers — AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. · Class II
Health-Tec/DHP Patient Bibs — Dental Health Products Inc · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI b5e9acb3-4f08-4224-b3d2-87ee4eca4890 33 fields · synced May 31, 2026