FDA UDI
In Commercial Distribution
🇺🇸 United States
DTK adhesive refill pack
DI: EBRE540011950
·
Model: 54001195
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DTK adhesive refill pack
- Primary DI
- EBRE540011950
- Version / Model
- 54001195
- Catalog Number
- 54001195
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e446629b-181c-40d3-a98d-9691f8c11f30
Device Description
DTK adhesive refill pack in a double mixing cartridge 1 x 8 g
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
- Yes
- 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 |
|---|---|---|---|---|
| KOL | ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPOLYMER | Dental | 872.3410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35877 | Dental repair kit, ceramic | A packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRE540011959 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2016-09-22 |
| Primary | EBRE540011950 | HIBCC |
Customer Contacts
- Phone
- +4907309872451
- [email protected]