FDA.reportPublic FDA data

KONTACT

Primary DI
03701045279518
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KECMD3
Device description
MagicDice I3 MU4.9
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701045279518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045279518037010452795183701045279518

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). 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

Regulatory Flags#

DUNS number
265382983
Device count
1
DM exempt
false
Premarket exempt
true
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
03701045246398KONTACTKEVFM2026-10-26
03701045278962KONTACTIRIS-SCANKIT2026-10-26
03701045278979KONTACTIRIS-SCANKITV2026-10-26
03701045279471KONTACTKECVMD2026-10-26
03701045279488KONTACTKECEVMD2026-10-26
03701045279495KONTACTKECMD12026-10-26
03701045279501KONTACTKECMD22026-10-26
03701045279525KONTACTKECMD42026-10-26
03701045279532KONTACTKECMD52026-10-26
03701045279549KONTACTKECMD62026-10-26
03701045279556KONTACTKECEMD12026-10-26
03701045279563KONTACTKECEMD22026-10-26
03701045279570KONTACTKECEMD32026-10-26
03701045279587KONTACTKECEMD42026-10-26
03701045279594KONTACTKECEMD52026-10-26
03701045279600KONTACTKECEMD62026-10-26
03701045279617KONTACTKECMDS12026-10-26
03701045279624KONTACTKECMDS22026-10-26
03701045279631KONTACTKECEMDS12026-10-26
03701045279648KONTACTKECEMDS22026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
05397311032789Driver Hex 0.9 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032796Driver Hex 1.2 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032802Driver Hex 1.3 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032819Angled DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032833SCS DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032840Unigrip DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032857Multi-Unit DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032864FlexDrive® Aluminium Tray PHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032895Driver BioHorizons 4.5HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032901Driver BioHorizons 5.7HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032918Driver Hiossen ET MiniHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26