RP Prosthetic Screw Internal Hex

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: RP Prosthetic Screw Internal Hex FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: For use with Natural Profile and UCLA-Type Abutments. Install with large external hex drivers (.048"). FDA UDI
Model / Reference: 904299 FDA UDI
Description: For use with Natural Profile and UCLA-Type Abutments. Install with large external hex drivers (.048"). FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549110900 FDA UDI
510(k) Number: K892124 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

RP Prosthetic Screw Internal Hex by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K892124 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: Sterngold Dental LLC

Sources (1)

FDA UDI 6ce14802-32d6-4d01-923a-d95ffacbfa87 36 fields · synced Jun 1, 2026