FDA UDI
In Commercial Distribution
🇺🇸 United States
ROGSON WAX, MDC Dental
DI: 07506338322355
·
Model: Self-Adhering Plastic Form
·
MDC DENTAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ROGSON WAX, MDC Dental
- Primary DI
- 07506338322355
- Version / Model
- Self-Adhering Plastic Form
- Company Name
- MDC DENTAL
- Labeler DUNS
- 811180298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 1
- Public Version Date
- 2024-12-26
- Public Version Status
- New
- Public Device Record Key
- 66d242bc-274b-4d9b-9bc4-9f28d1ac2a85
Device Description
Rogson Wax, Self-Adhering Plastic Form, Roach Type Retainer RC4 with 8 sheets
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EGD | Wax, Dental, Intraoral | Dental | 872.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16189 | Dental casting wax | A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07506338322355 | GS1 |
Customer Contacts
- Phone
- 3338330334
- [email protected]