FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Paradigm™
DI: 30605861037151
·
Model: 3710E
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Paradigm™
- Primary DI
- 30605861037151
- Version / Model
- 3710E
- Catalog Number
- 3710E
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-02
- Public Version Status
- Update
- Public Device Record Key
- c377cf3c-0048-41e2-b0bd-2fd8ab9e19a1
- Distribution End Date
- 2018-06-30
Device Description
3M™ ESPE™ Paradigm™ MZ100 Blocks for E4D™ System Refill, Shade Enamel, Size 10, 3710E
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38649 | Resin dental inlay | A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50605861037155 | GS1 | BOX | 10 | Not in Commercial Distribution | 2018-06-30 |
| Primary | 30605861037151 | GS1 | ||||
| Unit of Use | 00605861037150 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]