FDA.report

DS Implants

Primary DI
07392532279003
Brand
DS Implants
Company
Dentsply Implants Manufacturing GmbH
Model
68012239
Catalog number
68012239
Device description
MultiBase Temporary Cylinder
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532279003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532279003073925322790037392532279003

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
344038836
Device count
1
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
false
Sterilization required before use
false

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07392532207150SIMPLANT®54500175545001752026-03-10
07392532207112SIMPLANT®54500179545001792026-03-10
07392532207181SIMPLANT®54500180545001802026-03-10
07392532207068SIMPLANT®54500185545001852026-03-10
07392532207013SIMPLANT®54500187545001872026-03-10
07392532207266SIMPLANT®54500194545001942026-03-10
07392532236051SIMPLANT®54500197545001972026-03-10
07392532236020SIMPLANT®54500214545002142026-03-10
07392532281266ATLANTIS®68020074680200742025-12-18
07392532281280ATLANTIS®68020076680200762025-12-18
07392532215278ANKYLOS®31021100310211002020-11-18
07392532215285ANKYLOS®31021110310211102020-11-18
07392532215339ANKYLOS®31021160310211602020-11-18
07392532215353ANKYLOS®31021180310211802020-11-18
07392532215865ANKYLOS®31021630310216302020-11-18
07392532215896ANKYLOS®31021647310216472020-11-18
07392532215988ANKYLOS®31021660310216602020-11-18
07392532216572ANKYLOS®31022540310225402020-11-18

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07290120482678IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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