FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexcera Base Dark Pink
DI: 04260683220362
·
Model: RES-01-3142
·
Envisiontec GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flexcera Base Dark Pink
- Primary DI
- 04260683220362
- Version / Model
- RES-01-3142
- Catalog Number
- RES-01-3142
- Company Name
- Envisiontec GmbH
- Labeler DUNS
- 332025159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-06
- Public Version
- 1
- Public Version Date
- 2021-05-14
- Public Version Status
- New
- Public Device Record Key
- 712abfd6-c7d9-48c5-82c8-6290ef3a103e
Device Description
Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
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
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55831 | Denture base resin kit | A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260683220362 | GS1 |
Customer Contacts
- Phone
- +49204398750
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203641 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit