FDA UDI
In Commercial Distribution
🇺🇸 United States
Ena Bond ®
DI: EMICCOSM300A0
·
Model: COSM300A
·
MICERIUM SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ena Bond ®
- Primary DI
- EMICCOSM300A0
- Version / Model
- COSM300A
- Catalog Number
- COSM300A
- Company Name
- MICERIUM SPA
- Labeler DUNS
- 436661136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-08
- Public Version
- 4
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 4687a0b9-b8e9-4d39-9813-b8472599452d
Device Description
ENA-BOND ONE COMPONENT BONDING 5ml
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
- 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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EMICCOSM300A1 | HIBCC | PET-ALU-PE pouch | 1 | In Commercial Distribution | |
| Primary | EMICCOSM300A0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072978 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 3 – 25 Degrees Celsius