FDA UDI
In Commercial Distribution
🇺🇸 United States
Ceri-Prime
DI: D81313990
·
Model: 1399
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ceri-Prime
- Primary DI
- D81313990
- Version / Model
- 1399
- Catalog Number
- 1399
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 407b2a7e-275d-4f6d-a2cb-96ea8d890a92
Device Description
CERI-PRIME 15mL/PORC COND 6g
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
- Yes
- 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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36153 | Dental tooth-etching solution | An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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 | D81313990 | HIBCC |
Customer Contacts
- Phone
- 1-800-433-6628
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 47 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 47 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry location.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cold storage is not required