FDA.reportPublic FDA data

Derbarzt Edentulous Scanbody KIT Universal

Primary DI
08800303549426
Brand
Derbarzt Edentulous Scanbody KIT Universal
Company
HUB Biotech Co.,Ltd.
Model
UEDSBK
Catalog number
UEDSBK
Device description
Edentulous Scanbody KIT Universal
Published
2026-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
08800303549426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800303549426088003035494268800303549426

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695071932
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
08800303549174Derbarzt Edentulous ScanbodyAXFSBLAXFSBL2026-01-28
08800303549181Derbarzt Edentulous ScanbodyAXFSBL45LAXFSBL45L2026-01-28
08800303549198Derbarzt Edentulous ScanbodyAXFSBL45LBAXFSBL45LB2026-01-28
08800303549204Derbarzt Edentulous ScanbodyAXFSBL45RAXFSBL45R2026-01-28
08800303549211Derbarzt Edentulous ScanbodyAXFSBL45RBAXFSBL45RB2026-01-28
08800303549228Derbarzt Edentulous ScanbodyAXFSBLBAXFSBLB2026-01-28
08800303549235Derbarzt Edentulous ScanbodyAXFSBMAXFSBM2026-01-28
08800303549242Derbarzt Edentulous ScanbodyAXFSBMBAXFSBMB2026-01-28
08800303549259Derbarzt Edentulous ScanbodyAXFSBSAXFSBS2026-01-28
08800303549266Derbarzt Edentulous ScanbodyAXFSBSBAXFSBSB2026-01-28
08800303549273Derbarzt Edentulous ScanbodyAXMSBAXMSB2026-01-28
08800303549280Derbarzt Edentulous ScanbodyAXMSBBAXMSBB2026-01-28
08800303549297Derbarzt Edentulous ScanbodyFSBS_BFSBS_B2026-01-28
08800303549303Derbarzt Edentulous ScanbodyFSBS_GFSBS_G2026-01-28
08800303549310Derbarzt Edentulous ScanbodyFSBS_PFSBS_P2026-01-28
08800303549327Derbarzt Edentulous ScanbodyFSBS_YFSBS_Y2026-01-28
08800303549334Derbarzt Edentulous ScanbodyMSBBTMSBBT2026-01-28
08800303549341Derbarzt Edentulous ScanbodyMSBRLMSBRL2026-01-28
08800303549358Derbarzt Edentulous ScanbodyMSBRLWMSBRLW2026-01-28
08800303549365Derbarzt Edentulous ScanbodyMSBRMMSBRM2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03