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Essentials by 3D Dental

FDA UDI

Class I (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name
Essentials by 3D Dental FDA UDI
Generic Name
Implantable-device infection control barrier FDA UDI
Device Name
ESSENTIALS BARRIER FILM 4X6 CLEAR 1200/BX FDA UDI
Model / Reference
BARC FDA UDI
Description
ESSENTIALS BARRIER FILM 4X6 CLEAR 1200/BX FDA UDI

Identifiers

Catalog Number
BARC FDA UDI
Primary DI / UDI-DI
00817169023715 FDA UDI
FDA Product Code
NRD FDA UDI
GMDN Term
Implantable-device infection control barrier FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Implantable-device infection control barrier

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

Similar devices

Also classified as Implantable-device infection control barrier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Dental Designs And Development, Llc

Sources (1)

  • FDA UDI 080a89d8-99cc-481b-8a56-f73e21652fcd 34 fields · synced May 30, 2026