FDA.reportPublic FDA data

NA

Primary DI
07290112852236
Brand
NA
Company
UNIQA DENTAL LTD
Model
UMAD-0001
Catalog number
UMAD-0001
Device description
Analog MUA D-type
Published
2024-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290112852236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112852236072901128522367290112852236

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532098872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112853578NAUOTR-45551UOTR-455512024-09-04
07290112853592NAUOTR-45552UOTR-455522024-09-04
07290112853615NAUOTR-45553UOTR-455532024-09-04
07290112853639NAUOTR-45554UOTR-455542024-09-04
07290112853653NAUOTR-45555UOTR-455552024-09-04
07290112853677NAUOTR-50401UOTR-504012024-09-04
07290112853684NAUOTR-50551UOTR-505512024-09-04
07290112853691NAUOTR-50701UOTR-507012024-09-04
07290112853707NAUOTR-50402UOTR-504022024-09-04
07290112853714NAUOTR-50552UOTR-505522024-09-04
07290112853721NAUOTR-50702UOTR-507022024-09-04
07290112853738NAUOTR-50403UOTR-504032024-09-04
07290112853745NAUOTR-50553UOTR-505532024-09-04
07290112853752NAUOTR-50703UOTR-507032024-09-04
07290112853769NAUOTR-50404UOTR-504042024-09-04
07290112853776NAUOTR-50554UOTR-505542024-09-04
07290112853783NAUOTR-50704UOTR-507042024-09-04
07290112853790NAUOTR-50405UOTR-504052024-09-04
07290112853806NAUOTR-50555UOTR-505552024-09-04
07290112853813NAUOTR-50705UOTR-507052024-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03