FDA.report

3D Dental - Essentials

Primary DI
00817169021865
Brand
3D Dental - Essentials
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
DLJ-PPM
Catalog number
DLJ-PPM
Device description
LAB COAT PURPLE - MEDIUM 10/BAG
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications

CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817169021865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169021865008171690218658171690218650817169021865

GMDN Terms

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

Regulatory Flags

DUNS number
080194935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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008101265081713D DentalJSM-CW2026-03-16
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008101265081953D DentalJSM-W2026-03-16
00810126508201Essentials By 3D DentalPTC-Y2026-03-12
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00810126508225Essentials By 3D DentalPBBT-202026-03-11
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00810126508249Basik by 3D DentalBPGC316T2026-03-11
00810126508256Basik by 3D DentalBPGC304T2026-03-11
00810126508263Basik by 3D DentalBPGC303T2026-03-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110003MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158904MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158928MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158942MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
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