nt-Preform®

FDA UDI

Class II (US FDA UDI)

by NT-Trading GmbH & Co. KG

Identity

Trade Name: nt-Preform® FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Model / Reference: COL 10.MI3.300 FDA UDI

Identifiers

Catalog Number: COL 10.MI3.300 FDA UDI
Primary DI / UDI-DI: ENTTCOL10MI33001 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

nt-Preform® 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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NT-Trading GmbH & Co. KG

Sources (1)

FDA UDI a945abb6-6792-4f71-b4e3-72de774349f0 36 fields · synced Jun 8, 2026