FDA UDI
In Commercial Distribution
🇺🇸 United States
Vario-Soft-Steg vss
DI: EBRE430052700
·
Model: 43005270
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
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Basic Information
- Brand Name
- Vario-Soft-Steg vss
- Primary DI
- EBRE430052700
- Version / Model
- 43005270
- Catalog Number
- 43005270
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2023-09-20
- Public Version
- 1
- Public Version Date
- 2023-09-28
- Public Version Status
- New
- Public Device Record Key
- 09975e34-556a-431c-9550-313026f6ac06
Device Description
Vario-Soft-Steg vss Matrices, green 8 pieces
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
- 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 |
|---|---|---|---|---|
| EGG | ATTACHMENT, PRECISION, ALL | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38603 | Resilient dental precision attachment | A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRE430052709 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2023-09-20 |
| Primary | EBRE430052700 | HIBCC | ||||
| Unit of Use | EBRE430052708 | HIBCC |
Customer Contacts
- Phone
- +4907309872531
- [email protected]
- Phone
- +4907309872451
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 3.4 | Millimeter | |
| Height | 8.0 | Millimeter | |
| Length | 6.7 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry