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Straumann Magellan Abutment, Protective Cap, Titanium - Gold Copings, Basal Scr…
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- STRAUMANN MAGELLAN ABUTMENT,PROTECTIVE CAP,TITANIUM - GOLD COPINGS, BASAL SCREW FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- RC Screw-retained Abutment, TAN, straight 0°, Ø 4.6mm, GH 2.5mm, Pin FDA UDI
- Model / Reference
- Final Abutments FDA UDI
- Description
- RC Screw-retained Abutment, TAN, straight 0°, Ø 4.6mm, GH 2.5mm, Pin FDA UDI
Identifiers
- Catalog Number
- 022.4746P FDA UDI
- Primary DI / UDI-DI
- 07630031708984 FDA UDI
- 510(k) Number
- K133421 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
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 2.5 Millimeter FDA UDIOuter Diameter — 4.6 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Straumann Magellan Abutment, Protective Cap, Titanium - Gold Copings, Basal Scr… by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K133421 also covers:
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — Institut Straumann SA
- STRAUMANN MAGELLAN ABUTMENT, PROTECTIVE CAP, TITANIUM - GOLD COPINGS, BASAL SCREW — 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 8783208c-7737-4782-a87d-297fbd7b72b7 37 fields · synced Jun 1, 2026