FDA UDI
In Commercial Distribution
🇺🇸 United States
Vario-Soft 3 mini
DI: EBRE430073120
·
Model: 43007312
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
13
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Basic Information
- Brand Name
- Vario-Soft 3 mini
- Primary DI
- EBRE430073120
- Version / Model
- 43007312
- Catalog Number
- 43007312
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 13
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2068c8f6-17b4-46d8-8aa9-cdf72c147844
Device Description
Vario-Soft 3 mini 13 Parts 1 Assortment
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
- No
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38577 | Bar dental precision attachment | A small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRE430073129 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2016-09-27 |
| Primary | EBRE430073120 | HIBCC | ||||
| Unit of Use | EBRE430073128 | HIBCC |
Customer Contacts
- Phone
- +4907309872451
- [email protected]