FDA.reportPublic FDA data

Advance Dental Products

Primary DI
20850455007185
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
77502
Device description
Basic Procedure Earloop Masks, Pink
Published
2023-03-08
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

Product Codes#

Code, Name table
CodeName
FXXMask, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850455007185PackageGS110In Commercial Distribution
10850455007188PrimaryGS10
00850455007181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085045500718520850455007185
1085045500718810850455007188
00850455007181008504550071818504550071810850455007181

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
033505389
Device count
50
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00371347021974Advance Dental ProductsPR018HC2026-01-15
00371347022131Advance Dental ProductsPM018HC2026-01-15
00371347021028Advance Dental ProductsAPT1012026-01-15
00371347021035Advance Dental ProductsAPT1022026-01-15
00371347021042Advance Dental ProductsAPT1032026-01-15
00371347021059Advance Dental ProductsAPT1042026-01-15
00371347021066Advance Dental ProductsAPT1052026-01-15
00371347021073Advance Dental ProductsAPT1082026-01-15
00371347021080Advance Dental ProductsAPT1092026-01-15
00371347021097Advance Dental ProductsAPT1102026-01-15
00371347021103Advance Dental ProductsAPT1112026-01-15
00371347021110Advance Dental ProductsAPT1122026-01-15
00371347021127Advance Dental ProductsAPT1132026-01-15
00371347021134Advance Dental ProductsAPT1162026-01-15
00371347021141Advance Dental ProductsAPT1172026-01-15
00371347021158Advance Dental ProductsAPT1182026-01-15
00371347021165Advance Dental ProductsAPT1202026-01-15
00371347021172Advance Dental ProductsAPT1212026-01-15
00371347021189Advance Dental ProductsAPT1242026-01-15
00371347021196Advance Dental ProductsAPT1252026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20686864061933MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
00810194402715AiraAIRA, LLCFXX2026-03-10
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
00810126504395Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504449Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504456Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504494Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504616Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504623Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505651Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505668Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00817169029724The Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
30197344149388MEDLINEMEDLINE INDUSTRIES, INC.FXX2025-12-05
10842942017466PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20
10842942017473PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20