FDA UDI
In Commercial Distribution
🇺🇸 United States
Polibond 30 ml
DI: D800CPAD01010
·
Model: CPAD0101
·
ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Polibond 30 ml
- Primary DI
- D800CPAD01010
- Version / Model
- CPAD0101
- Company Name
- ZIRKONZAHN SRL
- Labeler DUNS
- 564251911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 94c25318-f35b-4234-9ce6-b5e029b6e250
Device Description
Content: Liquid for bonding Zirkonzahn Abro Basic Mono, Abro Basic Multistratum and Denture Gingiva Basic Mono resins as well as for polishing Zirkonzahn Multistratum Flexible and Temp Premium Flexible resins.
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
- 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 |
|---|---|---|---|---|
| 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 | D800CPAD01010 | HIBCC |
Customer Contacts
- Phone
- +390474066660
- [email protected]