Ceri-Prime
- Primary DI
- D81340213100
- Brand
- Ceri-Prime
- Company
- DEN-MAT HOLDINGS, LLC
- Model
- 4021310
- Catalog number
- 4021310
- Device description
- PORC LAM POLISH PST SY KIT
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
| EJR | Agent, Polishing, Abrasive, Oral Cavity |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D81340213100 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 36 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
| Special Storage Condition, Specify | 0 | 0 | Cold storage is not required |
| Special Storage Condition, Specify | 0 | 0 | Do not freeze |
| Special Storage Condition, Specify | 0 | 0 | Keep out of direct sunlight |
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dry location. |
| Storage Environment Temperature | 36 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 809857704
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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