FDA.reportPublic FDA data

KONTACT

Primary DI
03701045243786
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KVCK
Device description
Full healing screw Kit
Published
2021-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212068000Biotech Dental KitsBiotech Dental, Sas2021-11-08KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701045243786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045243786037010452437863701045243786

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
265382983
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
03701045206347KONTACTEAGPEAGP2022-12-05
03701045244943KONTACTKATLAFMKATLAFM2022-12-05
03701045244974KONTACTKATLA30MPICACKATLA30MPICAC2022-12-05
03701045244981KONTACTKATLA30MPICALKATLA30MPICAL2022-12-05
03701045245018KONTACTKATLAMPICAKATLAMPICA2022-12-05
03701045245025KONTACTKATLAMPICALKATLAMPICAL2022-12-05
03701045245087KONTACT60002021-12-01
03701045245100KONTACTKPKV2021-12-01
03701045245131KONTACTKTPIKV2021-12-02
03701045245148KONTACTKTPOKV2021-12-02
03701045245155KONTACTKSFE20KITV2021-12-02
03701045245179KONTACTKPJFKITV2021-12-02
03701045245186KONTACT102810282022-12-05
03701045245193KONTACTKATLAMTKATLAMT2022-12-05
03701045245421KONTACT103210322022-12-05
03701045245452KONTACT1033MAM-C1033MAM-C2022-12-05
03701045245469KONTACT1033MAM-L1033MAM-L2022-12-05
03701045245681KONTACTTCTPTCTP2022-12-05
03701045245711KONTACTESPESP2022-12-05
03701045245728KONTACTK30MPIMAM-CK30MPIMAM-C2022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26
00724995234416V. MuellerSteris CorporationKCT2026-08-26
00724995234423V. MuellerSteris CorporationKCT2026-08-26
00724995234430V. MuellerSteris CorporationKCT2026-08-26
00724995234447V. MuellerSteris CorporationKCT2026-08-26
00724995234454V. MuellerSteris CorporationKCT2026-08-26
00724995234461V. MuellerSteris CorporationKCT2026-08-26
00724995234478V. MuellerSteris CorporationKCT2026-08-26