FDA.reportPublic FDA data

KONTACT

Primary DI
03701045245452
Brand
KONTACT
Company
BIOTECH DENTAL
Model
1033MAM-C
Catalog number
1033MAM-C
Device description
Short hexagonal screwdriver for grinding handle
Published
2022-12-05
Public version status
Update
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
03701045245452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045245452037010452454523701045245452

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
true
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
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
00810157315182Ext. TransferParagon Implant Mfg., LLCNDP2026-09-21
00810157315199Ext. TransferParagon Implant Mfg., LLCNDP2026-09-21
00810157315205Extender AnalogParagon Implant Mfg., LLCNDP2026-09-21
00810157315212Extender AnalogParagon Implant Mfg., LLCNDP2026-09-21
03701045220763KONTACTBIOTECH DENTALNDP2026-09-21
03701045220770KONTACTBIOTECH DENTALNDP2026-09-21
03701045220787KONTACTBIOTECH DENTALNDP2026-09-21
03701045220794KONTACTBIOTECH DENTALNDP2026-09-21
03701045220800KONTACTBIOTECH DENTALNDP2026-09-21
03701045220817KONTACTBIOTECH DENTALNDP2026-09-21
03701045279037KONTACTBIOTECH DENTALNDP2026-09-21
03701045279044KONTACTBIOTECH DENTALNDP2026-09-21
03701045279051KONTACTBIOTECH DENTALNDP2026-09-21
03701045279068KONTACTBIOTECH DENTALNDP2026-09-21
03701045279075KONTACTBIOTECH DENTALNDP2026-09-21
03701045279082KONTACTBIOTECH DENTALNDP2026-09-21
03701045279099KONTACTBIOTECH DENTALNDP2026-09-21
03701045279105KONTACTBIOTECH DENTALNDP2026-09-21
03701045279112KONTACTBIOTECH DENTALNDP2026-09-21
03701045279129KONTACTBIOTECH DENTALNDP2026-09-21
03701045279136KONTACTBIOTECH DENTALNDP2026-09-21
03701045279143KONTACTBIOTECH DENTALNDP2026-09-21
03701045279150KONTACTBIOTECH DENTALNDP2026-09-21
03701045279167KONTACTBIOTECH DENTALNDP2026-09-21
03701045279174KONTACTBIOTECH DENTALNDP2026-09-21
03701045279181KONTACTBIOTECH DENTALNDP2026-09-21
03701045279198KONTACTBIOTECH DENTALNDP2026-09-21
03701045279204KONTACTBIOTECH DENTALNDP2026-09-21
03701045279211KONTACTBIOTECH DENTALNDP2026-09-21
03701045279228KONTACTBIOTECH DENTALNDP2026-09-21