FDA UDI
In Commercial Distribution
🇺🇸 United States
ODUS "PELLA" Transparent CROWN FORMS - Assortment of 36 crowns
DI: 07640159160458
·
Model: 33405d
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ODUS "PELLA" Transparent CROWN FORMS - Assortment of 36 crowns
- Primary DI
- 07640159160458
- Version / Model
- 33405d
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-28
- Public Version
- 1
- Public Version Date
- 2022-07-06
- Public Version Status
- New
- Public Device Record Key
- 33ef048c-344d-47a7-9f9d-4d7d0ae12ec7
Device Description
18 pairs (right and left) as described in the crown form chart (size 1, 11, 21, 31, 41, 51, 101, 111, 121, 131, 2, 12, 22, 32, 3, 13, 23, 5)
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 07640159160458 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]