LEONE SPA
- Primary DI
- 08033707023869
- Brand
- LEONE SPA
- Company
- LEONE SPA
- Model
- E2605-29
- Catalog number
- E2605-29
- Device description
- CALIBRA BANDS 2ND MOLAR n.SLR 29
- Published
- 2020-07-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ECM | Band, Preformed, Orthodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ECM | Band, Preformed, Orthodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08033707023869 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthodontic metal band | A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. |
Regulatory Flags
- DUNS number
- 432167294
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 10190707120327 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120334 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |