Prosthetic Screw 10PK, Straumann

FDA UDI

Class I (US FDA UDI)

by Smart Denture Conversions, Llc

Identity

Trade Name: Prosthetic Screw 10PK, Straumann FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Model / Reference: PS10PK-ST FDA UDI

Identifiers

Primary DI / UDI-DI: D990PS10PKST0 FDA UDI
FDA Product Code: EJX FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3130 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental prosthesis/implant abutment screw

Prosthetic Screw 10PK, Straumann by Smart Denture Conversions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Smart Denture Conversions, Llc

Sources (1)

FDA UDI 30b0ed68-d7cd-433b-9b62-73782c5cf043 33 fields · synced Jun 6, 2026