Identity
- Trade Name
- SM FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use 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
- MBTCP 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
- 08806343920935 FDA UDI
- 510(k) Number
- K221317 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Sm by Shinhung MST Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 |
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Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI c5c881a5-6f06-4351-a511-724b266271f7 35 fields · synced Jun 8, 2026