FDA UDI
In Commercial Distribution
🇺🇸 United States
MDC Dental
DI: 07506338301060
·
Model: Max Print Cyan
·
MDC DENTAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MDC Dental
- Primary DI
- 07506338301060
- Version / Model
- Max Print Cyan
- Company Name
- MDC DENTAL
- Labeler DUNS
- 811180298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-20
- Public Version
- 1
- Public Version Date
- 2022-01-28
- Public Version Status
- New
- Public Device Record Key
- 5356b136-7e6e-4641-8443-d2c73db524b6
Device Description
Type II normal setting alginate Metallic bag with 454 gr Removable and skeletal prostheses. Impression of removable, skeletal and total prosthodontics. Soft tissue impressions of the oral cavity and adjoining areas.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07506338301060 | GS1 |
Customer Contacts
- Phone
- +523338330333
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011785 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 23 Degrees Celsius