Custom Abutments

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: Custom Abutments FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: NC/RC Basal Screw AS, TAN FDA UDI
Model / Reference: Screws FDA UDI
Description: NC/RC Basal Screw AS, TAN FDA UDI

Identifiers

Catalog Number: 025.0076 FDA UDI
Primary DI / UDI-DI: 07630031745835 FDA UDI
510(k) Number: K243278 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental prosthesis/implant abutment screw

Custom Abutments by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw.

Azure — TERRATS MEDICAL SL. · Class II
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
Implant Prosthetics — PREAT Corporation · Class II
INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
MEDENTiKA — Medentika GmbH · Class II
Azure — TERRATS MEDICAL SL. · Class II

Cleared under the same submission

K243278 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: Institut Straumann SA

Sources (1)

FDA UDI 4697e1e5-63df-473a-9616-38df00d96cd3 36 fields · synced May 30, 2026