FDA.reportPublic FDA data

DD Scanbody 2.0

Primary DI
EDDIDDDFXST38S1
Brand
DD Scanbody 2.0
Company
Dental Direkt GmbH
Model
DFX 38 Set
Catalog number
DDDFXST38S
Device description
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.The Dental Direkt Scanbodies are used for digital acquisition of the implant position relative to the residual dentition and soft tissue.The Dental Direkt Scanbodies are available for various implant systems, are intended for optical acquisition and are screwed into the implant as a placeholder for intraoral scans or into the laboratory analog in the dental model.
Published
2023-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
EDDIDDDFXST38S1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+495225863190info@dentaldirekt.de

Regulatory Flags#

DUNS number
313214171
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
EDDIG520100001DD Bio ZW iso color98H10 1000G520100002024-08-27
EDDIG520133301DD Bio ZW iso color98H10 1333G520133302024-08-27
EDDIG2310011DD Bio ZX² color 71H14 lightG2310012016-10-05
EDDIG2310021DD Bio ZX² color 71H14 mediumG2310022016-10-05
EDDIG2310031DD Bio ZX² color 71H14 intenseG2310032016-10-05
EDDIG2310041DD Bio ZX² color 71H14 low chromaticG2310042016-10-05
EDDIG2310051DD Bio ZX² color 71H14 high chromaticG2310052016-10-05
EDDIG2320011DD Bio ZX² color 71H16 lightG2320012016-10-05
EDDIG2320021DD Bio ZX² color 71H16 mediumG2320022016-10-05
EDDIG2320031DD Bio ZX² color 71H16 intenseG2320032016-10-05
EDDIG2320041DD Bio ZX² color 71H16 low chromaticG2320042016-10-05
EDDIG2320051DD Bio ZX² color 71H16 high chromaticG2320052016-10-05
EDDIG2330011DD Bio ZX² color 71H20 lightG2330012016-10-05
EDDIG2330021DD Bio ZX² color 71H20 mediumG2330022016-10-05
EDDIG2330031DD Bio ZX² color 71H20 intenseG2330032016-10-05
EDDIG2330041DD Bio ZX² color 71H20 low chromaticG2330042016-10-05
EDDIG2330051DD Bio ZX² color 71H20 high chromaticG2330052016-10-05
EDDIG520200001DD Bio ZW iso color98H10 2000G520200002016-10-05
EDDIG52050001DD Bio ZW iso color98H10 500G52050002016-10-05
EDDIG52080001DD Bio ZW iso color98H10 800G52080002016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08