FDA.reportPublic FDA data

Healing abutment Regular

Primary DI
06947600310457
Brand
Healing abutment Regular
Company
BIO CONCEPT Co., Ltd.
Model
324030
Published
2020-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192274000BV Dental Implant SystemBio Concept Co., Ltd.2020-06-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947600310457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947600310457069476003104576947600310457

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
527603266
Device count
1
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
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
04251574835611MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
04251574835628MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
04251574853073MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
04251574862211MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
04251574862235MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
04251574862983MEDENTiKAMEDENTiKA GmbHNHA2026-06-23
08059224140179OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224141718OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150536OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150543OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150550OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150567OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150574OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150581OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150598OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150604OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150611OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150628OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150635OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150642OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150659OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150666OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150673OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224150680OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224151472OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224151489OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224155630OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224155913OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224194479OT EQUATORRHEIN 83 SRLNHA2026-06-23
08059224207339OT EQUATORRHEIN 83 SRLNHA2026-06-23