FDA.reportPublic FDA data

KONTACT

Primary DI
03701045278788
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KPBSH6550
Device description
BioScanHealer Ø6,5 H5mm
Published
2025-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K210220000
K213997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210220000Kontact Dental Implant SystemBiotech Dental, Sas2021-06-18DZE
K213997000Kontact Dental Implant SystemBiotech Dental, Sas2022-07-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701045278788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045278788037010452787883701045278788

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
265382983
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701045278603KONTACTK30PBSH302025-12-23
03701045278610KONTACTK30PBSH402025-12-23
03701045278627KONTACTK30PBSH502025-12-23
03701045278634KONTACTKPBSH40072025-12-23
03701045278641KONTACTKPBSH40102025-12-23
03701045278658KONTACTKPBSH40202025-12-23
03701045278665KONTACTKPBSH40302025-12-23
03701045278689KONTACTKPBSH40502025-12-23
03701045278696KONTACTKPBSH50072025-12-23
03701045278702KONTACTKPBSH50102025-12-23
03701045278719KONTACTKPBSH50202025-12-23
03701045278726KONTACTKPBSH50302025-12-23
03701045278733KONTACTKPBSH50402025-12-23
03701045278740KONTACTKPBSH50502025-12-23
03701045278757KONTACTKPBSH65202025-12-23
03701045278764KONTACTKPBSH65302025-12-23
03701045278771KONTACTKPBSH65402025-12-23
03701045278184KONTACTK30PBSH152025-12-24
03701045278672KONTACTKPBSH40402025-12-23
03701045276999KONTACTKPSSA5020KPSSA50202025-12-22

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Primary DI, Brand, Company table
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08800075201072I DoOneday Biotech Co.,Ltd.NHA2026-06-04
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08800075208613Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208620Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208637Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
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08800075208668Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
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08800075208712Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208729Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
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