ITLDental

FDA UDI

Class II (US FDA UDI)

by Emery Enterprises Inc.

Identity

Trade Name: ITLDental FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Long Head Screw for Multi-Unit Sleeve FDA UDI
Model / Reference: SMU-5022 FDA UDI
Description: Long Head Screw for Multi-Unit Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI: 00817686029146 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Screw endosteal dental implant, two-piece

ITLDental by Emery Enterprises Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
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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: Emery Enterprises Inc.

Sources (1)

FDA UDI 86d028ea-1b22-461f-9aa8-c819439df344 33 fields · synced Jun 8, 2026