FDA.reportPublic FDA data

Regular Scanbody for model

Primary DI
06947600314530
Brand
Regular Scanbody for model
Company
BIO CONCEPT Co., Ltd.
Model
362580
Published
2024-11-21
Public version status
Update
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
06947600314530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947600314530069476003145306947600314530

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527603266
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,Guided1595902026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,Guided1596002026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,Guided1596102026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,Guided1596202026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,Guided1596302026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,Guided1596402026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,Guided1596502026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,Guided1596602026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,Guided1596702026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,Guided1596802026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,Guided1596902026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,Guided1597002026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,Guided1597102026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,Guided1597202026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,Guided1597302026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,Guided1597402026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,Guided1597502026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,Guided1597602026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,Guided1597702026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,Guided1597802026-05-27

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