Stern IC RN UCLA Prosthetic Screw (S)

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: Stern IC RN UCLA Prosthetic Screw (S) FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: Intended for use with Stern IC dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI
Model / Reference: 904717 FDA UDI
Description: Intended for use with Stern IC dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549113314 FDA UDI
510(k) Number: K111798 FDA UDI
FDA Product Code: DZL FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4880 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

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

Stern IC RN UCLA Prosthetic Screw (S) by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111798 also covers:

Stern IC RN Solid Abutment 4.0mm — Sterngold Dental LLC

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: Sterngold Dental LLC

Sources (1)

FDA UDI f8bce925-4dbd-424d-83bb-b7d366e2e3a8 36 fields · synced May 30, 2026