PUR® Waxing Screw Long, 0.050 Hex

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: PUR® Waxing Screw Long, 0.050 Hex FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: Cylindrical stainless steel pins threaded at one end used for open tray impressions or as a pin to wax to when creating a crown. FDA UDI
Model / Reference: 904655 FDA UDI
Description: Cylindrical stainless steel pins threaded at one end used for open tray impressions or as a pin to wax to when creating a crown. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549117404 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: 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

Yes

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

Category: Dental prosthesis/implant abutment screw

PUR® Waxing Screw Long, 0.050 Hex by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental prosthesis/implant abutment screw.

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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

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 I	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI 8742272b-a8d7-4a04-a675-558db862efee 34 fields · synced May 30, 2026