FDA UDI
In Commercial Distribution
🇺🇸 United States
Porcelain Silane
DI: 07290115050462
·
Model: 400083
·
B.J.M. LABORATORIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Porcelain Silane
- Primary DI
- 07290115050462
- Version / Model
- 400083
- Company Name
- B.J.M. LABORATORIES LTD
- Labeler DUNS
- 514764117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-22
- Public Version
- 1
- Public Version Date
- 2023-11-30
- Public Version Status
- New
- Public Device Record Key
- 0b236496-908f-4cdf-a116-3b723e8be694
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KLE | AGENT, TOOTH BONDING, RESIN | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62474 | Dental prosthesis priming agent | A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. 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 | 07290115050462 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933766 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 24 Degrees Celsius