FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DS Implants
DI: 07392532263972
·
Model: 68012196
·
Dentsply Implants Manufacturing GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DS Implants
- Primary DI
- 07392532263972
- Version / Model
- 68012196
- Catalog Number
- 68012196
- Company Name
- Dentsply Implants Manufacturing GmbH
- Labeler DUNS
- 344038836
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-11
- Public Version
- 3
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- 179f05e7-04f1-438c-b64e-906195efd7d5
- Distribution End Date
- 2023-08-30
Device Description
MultiBase Abutment EV (M) 3.5mm NI
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 |
|---|---|---|---|---|
| NHA | Abutment, implant, dental, endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42354 | Transgingival implant | A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07392532263972 | GS1 |
Customer Contacts
- Phone
- +1(800)531-3481
- [email protected]