FDA.reportPublic FDA data

INTERNA 3.0 IMPLANT NON-ROTATING INTRAORAL SCAN BODY

Primary DI
08435389819509
Brand
INTERNA 3.0 IMPLANT NON-ROTATING INTRAORAL SCAN BODY
Company
BIOTECHNOLOGY INSTITUTE SL
Model
SBII31
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08435389819509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435389819509084353898195098435389819509

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
461665312
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435389830825INTERNA 3.0 IMPLANT EXTENSION, 24 MMEAI3242026-03-31
08435389830832INTERNA 3.0 IMPLANT EXTENSION, 29 MMEAI3292026-03-31
08435389830849IMPLANT EXTENSION; INTERNA NARROW; 15MMINEAE152026-03-31
08435389830856INTERNA NARROW IMPLANT EXTENSION, 24 MMINEAE242026-03-31
08435389830863INTERNA NARROW IMPLANT EXTENSION, 29 MMINEAE292026-03-31
08435389830870INTERNA UNIVERSAL IMPLANT EXTENSOR, 15 MMINEAU152026-03-31
08435389830887INTERNA UNIVERSAL IMPLANT EXTENSOR , 24 MMINEAU242026-03-31
08435389830894INTERNA UNIVERSAL IMPLANT EXTENSOR, 29 MMINEAU292026-03-31
08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30
08435389828969EXTRACTOR FOR IMPLANTS 9EXIM92026-01-30
08435389829027SHORT DRILL; Ø2,2 MMF22CS2026-01-30
08435389829034SHORT DRILL; Ø2,3 MMF23CS2026-01-30
08435389829041SHORT DRILL; Ø2,4 MMF24CS2026-01-30
08435389829058SHORT DRILL; Ø2,0 MMF20CS2026-01-30
08435389829096FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 FCFA55C2026-01-30
08435389830061EXTRA SHORT INITIAL DRILLFIXS2026-01-30
08435389830078EXTRA SHORT DRILL; Ø1,8 MMF18XS2026-01-30
08435389830085EXTRA SHORT DRILL; Ø1,8/2,5 MMF1825XS2026-01-30
08435389830092EXTRA SHORT DRILL; Ø2,5 MMF25XS2026-01-30
08435389830108EXTRA SHORT DRILL; Ø2,8 MMF28XS2026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08