Identity
- Trade Name
- DS Implants FDA UDI
- Generic Name
- Transgingival implant FDA UDI
- Device Name
- Abutment Screw EV (XS) FDA UDI
- Model / Reference
- 68012166 FDA UDI
- Description
- Abutment Screw EV (XS) FDA UDI
Identifiers
- Catalog Number
- 68012166 FDA UDI
- Primary DI / UDI-DI
- 07392532260582 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Transgingival implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
DS Implants by Dentsply Implants Manufacturing GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Implants Manufacturing GmbH
Sources (1)
- FDA UDI fc2bf0ab-7b59-4b7d-b4d3-fbd42fb7140d 35 fields · synced Jun 1, 2026