FDA.report

N/A

Primary DI
06009544009115
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
HB6
Device description
Temporary Healing Cap for Standard Abutment, Ø4.5 x 6mm
Published
2023-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NOKMaterial, External Aesthetic Restoration, No Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
NOKMaterial, External Aesthetic Restoration, No AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06009544009115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06009544009115060095440091156009544009115

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

Regulatory Flags

DUNS number
636239584
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06009544047810N/ABL-3M-112025-11-17
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06009544047872N/ABL-EL50-112025-11-17
06009544047889N/ABL-EL60-112025-11-17
06009544047896N/ABL-EX30-112025-11-17
06009544047902N/ABL-EX34-112025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840019971386Reform Ti ModularPRECISION SPINE, INC.NOK2026-01-13
06009544009108N/ASOUTHERN IMPLANTS (PTY) LTDNOK2023-07-04
00645517879284TrulifeTrulife LimitedNOK2022-12-31
00645517878881TrulifeTrulife LimitedNOK2022-12-31
00645517878898TrulifeTrulife LimitedNOK2022-12-31
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00645517878997TrulifeTrulife LimitedNOK2022-12-31
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00645517879031TrulifeTrulife LimitedNOK2022-12-31
00645517879048TrulifeTrulife LimitedNOK2022-12-31
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00645517879239TrulifeTrulife LimitedNOK2022-12-31
00645517879246TrulifeTrulife LimitedNOK2022-12-31
00645517879253TrulifeTrulife LimitedNOK2022-12-31
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