FDA.reportPublic FDA data

KONTACT

Primary DI
03701045278733
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KPBSH5040
Device description
BioScanHealer Ø5 H4mm
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
03701045278733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045278733037010452787333701045278733

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
03701045220763KONTACTWPSCANPA12026-09-21
03701045220770KONTACTWPSCANPA22026-09-21
03701045220787KONTACTWPSCANPA32026-09-21
03701045220794KONTACTWPSCANPA42026-09-21
03701045220800KONTACTWPSCANPA52026-09-21
03701045220817KONTACTWPSCANPA62026-09-21
03701045279037KONTACTKPSCANPA12026-09-21
03701045279044KONTACTKPSCANPA22026-09-21
03701045279051KONTACTKPSCANPA32026-09-21
03701045279068KONTACTKPSCANPA42026-09-21
03701045279075KONTACTKPSCANPA52026-09-21
03701045279082KONTACTKPSCANPA62026-09-21
03701045279099KONTACTKPSCANPLGA12026-09-21
03701045279105KONTACTKPSCANPLGA22026-09-21
03701045279112KONTACTKPSCANPLGA32026-09-21
03701045279129KONTACTKPSCANPLGA42026-09-21
03701045279136KONTACTKPSCANPLGA52026-09-21
03701045279143KONTACTKPSCANPLGA62026-09-21
03701045279150KONTACTK30PSCANPA12026-09-21
03701045279167KONTACTK30PSCANPA22026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23
088000968582178plant Implant System8dent Inc.NHA2026-10-23
088000968582248plant Implant System8dent Inc.NHA2026-10-23
088000968582318plant Implant System8dent Inc.NHA2026-10-23
088000968585528plant Implant System8dent Inc.NHA2026-10-23
088000968587058plant Implant System8dent Inc.NHA2026-10-23
088000968599008plant Implant System8dent Inc.NHA2026-10-23
088000968600298plant Implant System8dent Inc.NHA2026-10-23
088000968600508plant Implant System8dent Inc.NHA2026-10-23
088000968601808plant Implant System8dent Inc.NHA2026-10-23
088000968602038plant Implant System8dent Inc.NHA2026-10-23
088000968608768plant Implant System8dent Inc.NHA2026-10-23
088000968611948plant Implant System8dent Inc.NHA2026-10-23
088000968617368plant Implant System8dent Inc.NHA2026-10-23
088000968617438plant Implant System8dent Inc.NHA2026-10-23
088000968618288plant Implant System8dent Inc.NHA2026-10-23
088000968618358plant Implant System8dent Inc.NHA2026-10-23
088000968620098plant Implant System8dent Inc.NHA2026-10-23
088000968620168plant Implant System8dent Inc.NHA2026-10-23
088000968620238plant Implant System8dent Inc.NHA2026-10-23
088000968622698plant Implant System8dent Inc.NHA2026-10-23
088000968622768plant Implant System8dent Inc.NHA2026-10-23
088000968650248plant Implant System8dent Inc.NHA2026-10-23
088000968650798plant Implant System8dent Inc.NHA2026-10-23
088000968688418plant Implant System8dent Inc.NHA2026-10-23
088000968688588plant Implant System8dent Inc.NHA2026-10-23
088000968788338plant Implant System8dent Inc.NHA2026-10-23