Identity
- Trade Name
- Branemark WP 5.1 UCLA Non-Hex Cylinder FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- 44-500252-WP FDA UDI
Identifiers
- Catalog Number
- 44-500252-WP FDA UDI
- Primary DI / UDI-DI
- 10841307122401 FDA UDI
- 510(k) Number
- K904236 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
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
Category: Dental implant suprastructure, permanent, preformed
Branemark WP 5.1 UCLA Non-Hex Cylinder by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K904236 also covers:
- 3i 5.0mm Non-Hex Cylinder, .050"/1.25mm Hex Screw & Occlusal Plug — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Branemark NP 3.5 UCLA Hex Cylinder — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Branemark NP 3.5 UCLA Non-Hex Cylinder — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Branemark WP 5.1 UCLA Hex Cylinder — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Extra Long Branemark WP 5.1 .50"/1.25mm Hex Screw — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Extra Long Fixation Screw Multi-Use Uni- Torx — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Extra Long UCLA .050"/1.25mm Hex Screw Branemark RP 4.1 Compatible — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3 .050" Hex Screw — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3 Non-Hex Cylinder & .050"/1.25mm Hex Screw & Occlusal Plug — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0 Non-Hex Cylinder & .050"/1.25mm Hex Screw & Occlusal Plug — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0 Ti .050" Hex Screw (To Fit 4.0 IME & Complete Abutments) — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Multi-Use RP Non-Hex Cylinder & Uni-Torx Screw — IMPLANT DIRECT SYBRON MANUFACTURING LLC
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
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 29efc0dd-87f3-40dd-9661-8690dc51a08f 35 fields · synced Jun 6, 2026