FDA.reportPublic FDA data

KONTACT

Primary DI
03701045270645
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KPJFKIT
Device description
Try-in abutment Kit
Published
2021-12-02
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
03701045270645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045270645037010452706453701045270645

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
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
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
00642356006215Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006253SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006260SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006277SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006284SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006291SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006345SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006352SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006369SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006376SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006383SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006390SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006406SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006413SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006420SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006437SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006444SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006451SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006468SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006475SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006482SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006499SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006505SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006512SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006529SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006536SteriBestMastel Surgical Inc.KCT2026-10-22