Identity
- Trade Name
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- RN Solid All-In-One Set, gray, H 5.5mm, for bridge FDA UDI
- Model / Reference
- Final Abutments FDA UDI
- Description
- RN Solid All-In-One Set, gray, H 5.5mm, for bridge FDA UDI
Identifiers
- Catalog Number
- 040.841 FDA UDI
- Primary DI / UDI-DI
- 07630031717856 FDA UDI
- 510(k) Number
- K894844 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure kit
Bonefit Implant System Accessories & Instruments by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure kit.
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Cleared under the same submission
K894844 also covers:
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — 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 |
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Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI f19d2d95-1d02-48b9-a0d4-823a294f86e8 38 fields · synced May 30, 2026