FDA.report

NA

Primary DI
07290112859778
Brand
NA
Company
UNIQA DENTAL LTD
Model
ULCR-0004
Catalog number
ULCR-0004
Device description
Silicone cap for DLOC
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290112859778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290112859778072901128597787290112859778

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
532098872
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290112853110NAUSCD-0001USCD-00012024-11-06
07290112852236NAUMAD-0001UMAD-00012024-09-19
07290112852410NAUSDM-1508USDM-15082024-09-10
07290112852380NAUSDM-1515USDM-15152024-09-09
07290112852717NAUSDR-1510USDR-15102024-09-09
07290112852724NAUSDR-1515USDR-15152024-09-09
07290112852731NAUSDR-1507USDR-15072024-09-09
07290112852748NAUIDR-2410UIDR-24102024-09-09
07290112852755NAUIDR-2415UIDR-24152024-09-09
07290112852762NAUIDR-2407UIDR-24072024-09-09
07290118049463NAUIDM-0063UIDM-00632024-09-09
07290118176572NAUIDR-3410UIDR-34102024-09-09
07290118176589NAUIDR-3415UIDR-34152024-09-09
07290118176596NAUIDR-3420UIDR-34202024-09-09
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

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08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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