FDA.reportPublic FDA data

Essentials by 3D Dental

Primary DI
00817169023715
Brand
Essentials by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
BARC
Catalog number
BARC
Device description
ESSENTIALS BARRIER FILM 4X6 CLEAR 1200/BX
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817169023715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169023715008171690237158171690237150817169023715

GMDN Terms#

Term, Definition table
TermDefinition
Implantable-device infection control barrierA sterile, bioabsorbable, implantable substance intended to be applied as a protective barrier over the surface of an implantable device (e.g., orthopaedic prosthesis) prior to implantation to prevent bacterial adhesion, colonization, and biofilm formation through physical means only; it may be used in conjunction with a separate antimicrobial agent. It contains microbe-derived materials [e.g., hyaluronic acid (HA)] and may be supplied in dry form (e.g., powder) intended to be hydrated prior to use; disposable devices associated with application/preparation (e.g., syringes, adaptors, application nozzle) may be included. This is a single-use device.

Regulatory Flags#

DUNS number
080194935
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08