Identity
- Trade Name
- Branemark Multi-Use RP Abutment 4.0mm FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- 43-501040 FDA UDI
Identifiers
- Catalog Number
- 43-501040 FDA UDI
- Primary DI / UDI-DI
- 10841307118220 FDA UDI
- 510(k) Number
- K863680 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Branemark Multi-Use RP Abutment 4.0mm by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- 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
K863680 also covers:
- Branemark Multi-Use RP Abutment 2.0mm — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Branemark Multi-Use RP Abutment 3.0mm — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3mm Diameter Ti IMC 2mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3mm Diameter Ti IMC 3mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3mm Diameter Ti IMC 4mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3mm Diameter Ti IMC Conversion Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 3.3mm Titanium IME - 2mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0 mm Diameter Ti IMC 4mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0mm Titanium IMC - 1.0mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0mm Titanium IMC - 2.0mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0mm Titanium IMC - 3.0mm Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- IMZ 4.0mm Titanium IME - 2mm Abutment — 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 8fdcc8fd-3fc8-411a-a6a8-9c7f9b9b07f5 35 fields · synced May 30, 2026