FDA.reportPublic FDA data

3D DENTAL-ESSENTIALS

Primary DI
00817169022190
Brand
3D DENTAL-ESSENTIALS
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
DJ-PKM
Catalog number
DJ-PKM
Device description
3D DENTAL JACKET PINK MEDIUM 10/PKG
Published
2023-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-surgical isolation gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817169022190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169022190008171690221908171690221900817169022190

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)605-8061cs@3d-dent.com

Regulatory Flags#

DUNS number
080194935
Device count
1
DM exempt
true
Premarket exempt
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
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13