Identity
- Trade Name
- Custom Abutments FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Custom Abutment AS Ti, for Straumann RN, incl. TAN screw FDA UDI
- Model / Reference
- Final Abutments FDA UDI
- Description
- Custom Abutment AS Ti, for Straumann RN, incl. TAN screw FDA UDI
Identifiers
- Catalog Number
- 010.5439 FDA UDI
- Primary DI / UDI-DI
- 07630031773944 FDA UDI
- 510(k) Number
- K243278 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Custom Abutments by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243278 also covers:
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
- Custom Abutments — Institut Straumann SA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI a847802e-1bc1-4d4b-b88c-59a5c6124800 36 fields · synced May 30, 2026