Identity
- Trade Name
- SM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading. FDA UDI
- Model / Reference
- MB2511SR FDA UDI
- Description
- The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806343919731 FDA UDI
- 510(k) Number
- K221317 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, one-piece
Sm by Shinhung MST Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K221317 also covers:
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
- SM — Shinhung MST Co., Ltd.
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
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI 96d1e13e-d92d-4c7d-ac73-218ca85bc491 35 fields · synced Jun 8, 2026