ITLDental

FDA UDI

Class I (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: 35Ncm Torque Wrench with Diamondent Logo FDA UDI
Model / Reference: GTW-35D FDA UDI
Description: 35Ncm Torque Wrench with Diamondent Logo FDA UDI

Identifiers

Primary DI / UDI-DI: 00817686029023 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece 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

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

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: Screw endosteal dental implant, two-piece

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

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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 I	Pending data

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Manufacturer

Manufacturer: Emery Enterprises Inc.

Sources (1)

FDA UDI 2b69961c-a563-40be-b9b8-763b8d1a5218 33 fields · synced Jun 8, 2026