FDA UDI
In Commercial Distribution
🇺🇸 United States
breCAM.HIPC
DI: EBRE540033980
·
Model: 54003398
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- breCAM.HIPC
- Primary DI
- EBRE540033980
- Version / Model
- 54003398
- Catalog Number
- 54003398
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 1
- Public Version Date
- 2023-09-25
- Public Version Status
- New
- Public Device Record Key
- 4f6fb92d-1f69-406e-a773-c209cab8027b
Device Description
breCAM.HIPC Ø 98.4 x 20mm bleach 1 Piece
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ELM | Denture, plastic, teeth | Dental | 872.3590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62817 | Dental appliance fabrication material, combination-material | A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRE540033989 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2023-09-15 |
| Primary | EBRE540033980 | HIBCC |
Customer Contacts
- Phone
- +4907309872531
- [email protected]
- Phone
- +4907309872451
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 20 | Millimeter | |
| Outer Diameter | 98.4 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight