← Back to catalogue

A0620x08

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref A0620X08Model FIXED EXPANDER

by Leone S.p.a.

Identity

Trade Name
LEONE SPA FDA UDI
Generic Name
Orthodontic retainer FDA UDI
Device Name
EXPABENT PALATAL SCREW 8MM . FDA UDI
Model / Reference
FIXED EXPANDER EUDAMED
A0620X08 EUDAMEDFDA UDI
Description
EXPABENT PALATAL SCREW 8MM . FDA UDI

Identifiers

Catalog Number
A0620X08 FDA UDI
Primary DI / UDI-DI
08033707093961 EUDAMEDFDA UDI
Basic UDI-DI
080337070TDIIA001M03-8J EUDAMED
FDA Product Code
DYJ FDA UDI
JEX FDA UDI
EMDN Code
Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
GMDN Term
Orthodontic retainer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.5410 FDA UDI
872.4565 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

At LEONE S.P.A., we design and manufacture high-quality medical devices with a focus on innovation, precision, and customer satisfaction. Our A0620X08 device is a Class IIa instrument that meets the latest regulatory requirements for sterilization and safety.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Leone S.p.a.
EUDAMED SRN
IT-MF-000005986

Sources (2)

  • EUDAMED 79dd8ca2-692d-4501-b25e-40e15a97d67c 61 fields · synced Jul 3, 2026
  • FDA UDI 797da750-0c1a-431c-b827-a8e0937af95b 34 fields · synced May 30, 2026