FDA.reportPublic FDA data

KONTACT

Primary DI
03701045270485
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KPSTA150501
Device description
Non scalloped angulated 15° standard abutment Ø5.0mm H1mm + screwKVP
Published
2021-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701045270485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045270485037010452704853701045270485

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)277-5662info@biotechdentalusa.com

Regulatory Flags#

DUNS number
265382983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08809918260054LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809918260085LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809984988135S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988210S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988296S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988333S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988371S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988418S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988456S-PlantIDIS CO.,LTDNHA2026-10-22
08809984987886S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987909S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987923S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987947S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987961S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987985S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988005S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988029S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988043S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988067S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988098S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988173S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988258S-PlantIDIS CO.,LTDNHA2026-10-21
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20