FDA UDI
In Commercial Distribution
🇺🇸 United States
DS Implants
DI: 07392532278693
·
Model: 68012202
·
Dentsply Implants Manufacturing GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DS Implants
- Primary DI
- 07392532278693
- Version / Model
- 68012202
- Catalog Number
- 68012202
- Company Name
- Dentsply Implants Manufacturing GmbH
- Labeler DUNS
- 344038836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-08
- Public Version
- 1
- Public Version Date
- 2023-02-16
- Public Version Status
- New
- Public Device Record Key
- 51082104-5a03-47e9-acc5-5a55ce79ea0f
Device Description
MultiBase Abutment EV (M) 1.5mm 17° 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
- MR Conditional
- 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
- Yes
- 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 | 07392532278693 | GS1 |