FDA.reportPublic FDA data

KONTACT

Primary DI
03701045246398
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KEVFM
Device description
Drill for broken screw extraction
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
true

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
03701045246398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045246398037010452463983701045246398

GMDN Terms#

Term, Definition table
TermDefinition
Screw extractor, single-useA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a single-use 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
03701045278962KONTACTIRIS-SCANKIT2026-10-26
03701045278979KONTACTIRIS-SCANKITV2026-10-26
03701045279471KONTACTKECVMD2026-10-26
03701045279488KONTACTKECEVMD2026-10-26
03701045279495KONTACTKECMD12026-10-26
03701045279501KONTACTKECMD22026-10-26
03701045279518KONTACTKECMD32026-10-26
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
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH 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
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05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032833SCS DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
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