FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO Resins Denture Fix
DI: 04260635981365
·
Model: 019.3233
·
DeltaMed GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRO Resins Denture Fix
- Primary DI
- 04260635981365
- Version / Model
- 019.3233
- Catalog Number
- 019.3233
- Company Name
- DeltaMed GmbH
- Labeler DUNS
- 344805101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-23
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- 0aae64d4-e155-46d3-a178-d89ea50da510
Device Description
PRO Resins Denture Fix 8g
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
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63626 | Dental prosthesis-component adhesive | A non-sterile adhesive material (e.g., self- or light-cured polymer composite) intended to be used to bond together components of a restorative dental prosthesis [e.g., crown, removable denture] by functioning as a glue between metal, synthetic, and/or ceramic materials; it is not intended to bond prosthetic devices to patient tissues (e.g., oral mucosa, teeth). Dedicated disposable devices associated with application [e.g., brush, mixing tip] may be included. 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 | 04260635981365 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212541 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- avoid direct sunlight