FDA.reportPublic FDA data

KONTACT

Primary DI
03701045279129
Brand
KONTACT
Company
BIOTECH DENTAL
Model
KPSCANPLGA4
Device description
I4-Long scanbody
Published
2026-09-21
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
03701045279129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701045279129037010452791293701045279129

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
+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
03701045279136KONTACTKPSCANPLGA52026-09-21
03701045279143KONTACTKPSCANPLGA62026-09-21
03701045279150KONTACTK30PSCANPA12026-09-21
03701045279167KONTACTK30PSCANPA22026-09-21
03701045279174KONTACTK30PSCANPA32026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002021Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002038Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002045Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002052Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002076Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14