Identity
- Trade Name
- Smileloc® BY RODO FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Regular Multi-Unit Ti Abutment, Straight. GH 4.0 mm. Compatible with Nobel Tri-Channel RP FDA UDI
- Model / Reference
- 50040NBR221 FDA UDI
- Description
- Regular Multi-Unit Ti Abutment, Straight. GH 4.0 mm. Compatible with Nobel Tri-Channel RP FDA UDI
Identifiers
- Catalog Number
- 50040NBR221 FDA UDI
- Primary DI / UDI-DI
- 00816131021575 FDA UDI
- 510(k) Number
- K160786 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
Smileloc BY RODO is a pre-fabricated dental implant superstructure designed for permanent intermediate fixture level applications. It features a straight, regular multi-unit Ti abutment with a GH 4.0 mm diameter and Nobel Tri-Channel RP material. The device includes an abutment screw(s) that may be included in the suprastructure, but is not represented in isolation.
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
K160786 also covers:
- Rodo Abutment Accessories — RODO MEDICAL, INC
- Rodo Abutment Accessories — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
- Smileloc® BY RODO — RODO MEDICAL, INC
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Rodo Medical, Inc
Sources (1)
- FDA UDI 34abaae3-b151-4e1c-94dc-b8e0c32c015d 36 fields · synced Jul 18, 2026