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2-CONnect®

FDA UDI

Class II (US FDA UDI)

by NT-Trading GmbH & Co. KG

Identity

Trade Name
2-CONnect® FDA UDI
Generic Name
Dental prosthesis/implant abutment screw FDA UDI
Model / Reference
COL-2CON 8038432M FDA UDI

Identifiers

Catalog Number
COL-2CON 8038432M FDA UDI
Primary DI / UDI-DI
ENTTCOL2CON8038432M1 FDA UDI
510(k) Number
K111935 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

2-CONnect® by NT-Trading GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111935 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NT-Trading GmbH & Co. KG

Sources (1)

  • FDA UDI d7f07799-8477-4649-a338-e4f2de797a28 36 fields · synced Jun 8, 2026