FDA UDI
Not in Commercial Distribution
🇺🇸 United States
breCAM.BioHPP TU
DI: EBRE540T21010
·
Model: 540T2101
·
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.BioHPP TU
- Primary DI
- EBRE540T21010
- Version / Model
- 540T2101
- Catalog Number
- 540T2101
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2023-12-06
- Public Version Status
- Update
- Public Device Record Key
- c2011001-be91-4cfc-be02-8298dff24c1d
- Distribution End Date
- 2023-12-04
Device Description
breCAM.BioHPP TU Ø 95 x 20mm ZZ dentin-shade 2 1 Piece
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
- No
- 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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37542 | Dental bridge, polymer | A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRE540T21019 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2016-09-20 |
| Primary | EBRE540T21010 | HIBCC |
Customer Contacts
- Phone
- +4907309872451
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry