FDA.reportPublic FDA data

2-CONnect®

Primary DI
ENTTHIO2CON8040602S1
Brand
2-CONnect®
Company
NT-Trading GmbH & Co. KG
Model
HIO-2CON 8040602S
Catalog number
HIO-2CON 8040602S
Published
2019-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111935000TI-BASE ABUTMENT, 1 CONNECT ABUTMENTNt-Trading GmbH and CO KG2012-02-17NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTTHIO2CON8040602S1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
312800478
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTTTA9S3D3745N/ATA 9.S33D3.7452023-10-16
ENTTBEG9S3D32371NABEG 9.S3D3.237BEG 9.S3D3.2372023-07-21
ENTTBEG9S3D41001NABEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001NABEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001NABEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBIO9S3D30001NABIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001NABIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001NABIO 9.S3D4.500BIO 9.S3D4.5002023-07-21
ENTTBIO9S3D57001NABIO 9.S3D5.700BIO 9.S3D5.7002023-07-21
ENTTBRE9S3D35401NABRE 9.S3D3.540BRE 9.S3D3.5402023-07-21
ENTTCAM9S3D33001NACAM 9.S3D3.300CAM 9.S3D3.3002023-07-21
ENTTCAM9S3D38001NACAM 9.S3D3.800CAM 9.S3D3.8002023-07-21
ENTTCAM9S3D43001NACAM 9.S3D4.300CAM 9.S3D4.3002023-07-21
ENTTCAM9S3D50601NACAM 9.S3D5.060CAM 9.S3D5.0602023-07-21
ENTTCOL9S3D33001NACOL 9.S3D3.300COL 9.S3D3.3002023-07-21
ENTTCOL9S3D38431NACOL 9.S3D3.843COL 9.S3D3.8432023-07-21
ENTTCOL9S3D50001NACOL 9.S3D5.000COL 9.S3D5.0002023-07-21
ENTTE9S3D35001NAE 9.S3D3.500E 9.S3D3.5002023-07-21
ENTTE9S3D43001NAE 9.S3D4.300E 9.S3D4.3002023-07-21
ENTTE9S3D50001NAE 9.S3D5.000E 9.S3D5.0002023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06