FDA UDI
In Commercial Distribution
🇺🇸 United States
Ena Post
DI: EMICCPF10071
·
Model: CPF1007
·
MICERIUM SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Ena Post
- Primary DI
- EMICCPF10071
- Version / Model
- CPF1007
- Catalog Number
- CPF1007
- Company Name
- MICERIUM SPA
- Labeler DUNS
- 436661136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-05-03
- Public Version
- 1
- Public Version Date
- 2023-05-11
- Public Version Status
- New
- Public Device Record Key
- 177c4a3a-034f-44c4-8261-af3a8ba69ed7
Device Description
Ena Post ENAPOST Fiber Post Conicity 10%
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJL | Bur, Dental | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35868 | Dental restoration retention pin | A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EMICCPF10070 | HIBCC | ||||
| Primary | EMICCPF10071 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.8 | Millimeter | |
| Outer Diameter | 0.7 | Millimeter |