FDA UDI
In Commercial Distribution
🇺🇸 United States
SeptoMatrix Sectional Refill: 50 assorted matrices
DI: 07897990328459
·
Model: 01C4014
·
SEPTODONT SAS SPECIALITES SEPTODONT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SeptoMatrix Sectional Refill: 50 assorted matrices
- Primary DI
- 07897990328459
- Version / Model
- 01C4014
- Catalog Number
- 01C4014
- Company Name
- SEPTODONT SAS SPECIALITES SEPTODONT
- Labeler DUNS
- 275273795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-16
- Public Version
- 2
- Public Version Date
- 2025-03-12
- Public Version Status
- Update
- Public Device Record Key
- 3e554377-f87c-4ff9-b1d1-d9ab087073ae
Device Description
Preformed sectional matrices systems for Class II restorations.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKF | Instrument, Contouring, Matrix, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38786 | Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07897990328459 | GS1 |