Identity
- Trade Name
- Barrier FDA UDI
- Generic Name
- Dental bib FDA UDI
- Device Name
- Disposable dental bib connnector with tape FDA UDI
- Model / Reference
- DC-0115S FDA UDI
- Description
- Disposable dental bib connnector with tape FDA UDI
Identifiers
- Catalog Number
- DC-0115S-1 FDA UDI
- Primary DI / UDI-DI
- H816DC0115S1 FDA UDI
- 510(k) Number
- K922175 FDA UDI
- FDA Product Code
- KLC FDA UDI
- GMDN Term
- Dental bib FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6250 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental bib
Barrier by Certol International, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bib.
- Pac-Dent — Pac-Dent International, Inc. · Class II
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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
Cleared under the same submission
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
- Certol International, Llc
Sources (1)
- FDA UDI 42872f93-4783-4b3b-ac11-6e9a92d16a69 35 fields · synced May 30, 2026