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Orthodontic Bands

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref E1535-25

by Leone S.p.a.

Identity

Trade Name
LEONE SPA FDA UDI
Generic Name
Orthodontic metal band FDA UDI
Device Name
Orthodontic Bands EUDAMED
CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 25 FDA UDI
Model / Reference
E1535-25 EUDAMEDFDA UDI
Description
CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 25 FDA UDI

Identifiers

Catalog Number
E1535-25 FDA UDI
Primary DI / UDI-DI
08033707015178 EUDAMEDFDA UDI
Basic UDI-DI
B-08033707015178 EUDAMED
FDA Product Code
ECM FDA UDI
EMDN Code
Q010402 ORTHODONTIC BANDS EUDAMED
GMDN Term
Orthodontic metal band FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.5410 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

Discover the Orthodontic Bands, a revolutionary orthodontic treatment that utilizes precision-engineered bands to gently guide teeth into optimal alignment. With its innovative design and advanced materials, this device is designed to provide long-lasting results with minimal discomfort.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

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 dd451247-edfb-485a-9cff-dab2c395645d 61 fields · synced Jul 20, 2026
  • FDA UDI 0af0a345-6dba-44c6-bfb9-8b7c132c44ae 34 fields · synced May 29, 2026