FDA.reportPublic FDA data

ATOMO

Primary DI
D883AA02111
Brand
ATOMO
Company
ATOMO DENTAL, INC.
Model
AA0211
Device description
ATOMO Handpiece Sleeves -2
Published
2022-09-09
Public version status
Update
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
D883AA02113PackageHIBCC36In Commercial Distribution
D883AA02111PrimaryHIBCC0
D883AA02110Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
088480717
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D883AA02101ATOMOAA02102022-09-09
D883AA02201ATOMOAA02202022-09-08
D883AA02381ATOMOAA02382022-09-08
D883AA02391ATOMOAA02392022-09-08
D883AA02501ATOMOAA02502022-09-06
D883AA02601ATOMOAA02602022-09-08
D883AA02611ATOMOAA02612022-09-08
D883AA02621ATOMOAA02622022-09-09
D883AA02701ATOMOAA02702022-09-08
D883AA02711ATOMOAA02712022-09-08
D883AA02811ATOMOAA02812022-09-08
D883AA02821ATOMOAA02822022-09-08
D883AA08811ATOMOAA08812022-09-09
D883AA08831ATOMOAA08832022-09-09
D883AA08841ATOMOAA08842022-09-09
D883AA12401ATOMOAA12402022-09-05
D883AA12421ATOMOAA12422022-09-05
D883AA12431ATOMOAA12432022-09-05
D883AA12461ATOMOAA12462022-09-05
D883AA12471ATOMOAA12472022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
D678AS50X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
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