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Essentials

FDA UDI

Class I (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name
Essentials FDA UDI
Generic Name
Dental bib FDA UDI
Device Name
Chair Sleeve Full 29"X80" 125/Bx Case/3 FDA UDI
Model / Reference
PL-FCS-CS FDA UDI
Description
Chair Sleeve Full 29"X80" 125/Bx Case/3 FDA UDI

Identifiers

Catalog Number
PL-FCS-CS FDA UDI
Primary DI / UDI-DI
00817169029434 FDA UDI
FDA Product Code
NRU 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

Yes

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

Essentials by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bib.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 817b7750-9569-4e1f-9cac-711c9fcec52f 34 fields · synced Jun 7, 2026