TruFit™
- Primary DI
- 10190707190870
- Brand
- TruFit™
- Company
- Ortho Organizers, Inc.
- Model
- 495-00-4600-305-3
- Device description
- TruFit 2.0 Molar Band LL6 Size: 30.5 (3PK)
- Published
- 2025-10-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- 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 |
|---|
| 00190707190873 | Primary | GS1 | 0 | |
| 10190707190870 | Unit of Use | 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
- 062165188
- Device count
- 3
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00840018667815 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | ECM | 2025-11-06 |
| 10190707120051 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120068 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120075 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120082 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120099 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120105 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120112 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120129 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120136 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120143 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120150 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120167 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120174 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120181 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120198 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120204 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120211 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120228 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120235 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120242 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120259 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120266 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120273 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120280 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120297 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120303 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120310 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120327 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |
| 10190707120334 | TruFit™ 2.0 | Ortho Organizers, Inc. | ECM | 2025-10-17 |