Leone Spa

FDA UDI

Class I (US FDA UDI)

by Leone Spa

Identity

Trade Name: LEONE SPA FDA UDI
Generic Name: Orthodontic anchoring screw FDA UDI
Device Name: MINI ORTHODONTIC IMPLANT KIT W/GROOVE FDA UDI
Model / Reference: 001-0002-24 FDA UDI
Description: MINI ORTHODONTIC IMPLANT KIT W/GROOVE FDA UDI

Identifiers

Catalog Number: 001-0002-24 FDA UDI
Primary DI / UDI-DI: 08033707071600 FDA UDI
FDA Product Code: NDP FDA UDI
EJL FDA UDI
EKD FDA UDI
OAT FDA UDI
GMDN Term: Orthodontic anchoring screw FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
872.3240 FDA UDI
872.4565 FDA UDI
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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic anchoring screw

Leone Spa by Leone Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic anchoring screw.

Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Absoanchor Microimplant — DENTOS Inc. · Class II
Absoanchor Microimplant — DENTOS Inc. · Class II
GBR System Bone Screw — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · 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: Leone Spa

Sources (1)

FDA UDI f04f9e3f-82c6-4481-9137-b3cec163876f 34 fields · synced May 30, 2026