FDA UDI
In Commercial Distribution
🇺🇸 United States
Fusion Bond 7
DI: D96710001
·
Model: Intro Pack
·
PREVEST DENPRO LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fusion Bond 7
- Primary DI
- D96710001
- Version / Model
- Intro Pack
- Catalog Number
- 10001
- Company Name
- PREVEST DENPRO LIMITED
- Labeler DUNS
- 859546940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 1
- Public Version Date
- 2024-05-01
- Public Version Status
- New
- Public Device Record Key
- 71334b26-37c9-4d05-af62-d2cdad38cd4f
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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63592 | Dental acrylic resin kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes acrylic resin material (without hardening fillers/materials) and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prostheses. 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 | D96710001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231696 | 000 |