FDA.report

Essentials by 3D Dental

Primary DI
00810126504456
Brand
Essentials by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
1
Catalog number
EAR-P
Device description
Earloop Masks 50/Bx Pink
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXXMask, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810126504456PrimaryGS10

GMDN Terms

TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
008101265062213D DentalRCPC2026-03-24
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00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16
00810126508201Essentials By 3D DentalPTC-Y2026-03-12
008171690293113D DentalKF21082026-03-12
00810126508218Essentials By 3D DentalPBBT-1002026-03-11
00810126508225Essentials By 3D DentalPBBT-202026-03-11
00810126508232Basik by 3D DentalBPGC345T2026-03-11
00810126508249Basik by 3D DentalBPGC316T2026-03-11
00810126508256Basik by 3D DentalBPGC304T2026-03-11
00810126508263Basik by 3D DentalBPGC303T2026-03-11

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00810194402746AiraAIRA, LLCFXX2026-03-10
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
00068113110610EquateWAL-MART STORES, INC.FXX2026-02-25
10612479275932McKessonMCKESSON MEDICAL-SURGICAL INC.FXX2026-02-20
08809755250164KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
00810132808135House Brand DentistryFrontier Dental Supply IncFXX2026-02-10
30197344179750MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-29
10311917079629WalgreensWALGREEN CO.FXX2026-01-22
30197344153163MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-21
00810194402678AiraAIRA, LLCFXX2026-01-16
00810194402692AiraAIRA, LLCFXX2026-01-16
00810194402708AiraAIRA, LLCFXX2026-01-16
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box BlackPRACTICON, INC.FXX2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box BluePRACTICON, INC.FXX2026-01-08
00850025515092BAYLAB USABaylab USA, LLCFXX2026-01-05
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00810126504449Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
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30197344149388MEDLINEMEDLINE INDUSTRIES, INC.FXX2025-12-05
10842942017466PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20
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