FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ ESPE™ Protemp™
DI: 30605861007352
·
Model: 50616
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- 3M™ ESPE™ Protemp™
- Primary DI
- 30605861007352
- Version / Model
- 50616
- Catalog Number
- 50616
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 2
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 7df8830c-cf90-4707-837d-1b0d4a3565b8
Device Description
3M™ ESPE™ Protemp™ Crown Temporization Material Refill - Bicuspid Lower, 50616
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
- 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 |
|---|---|---|---|---|
| ELZ | CROWN, PREFORMED | Dental | 872.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34976 | Preformed dental crown, temporary | A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50605861007356 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 30605861007352 | GS1 | ||||
| Unit of Use | 00605861007351 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]