Identity
- Trade Name
- SM3 FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. FDA UDI
- Model / Reference
- S200EL FDA UDI
- Description
- S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995229 FDA UDI
- FDA Product Code
- KMW FDA UDIEGS FDA UDIEBW FDA UDI
- GMDN Term
- Dental power tool system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool system handpiece, line-powered
Sm3 by Osstem Implant Co., Ltd._Gasan Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Osstem Implant Co., Ltd._Gasan Branch
Sources (1)
- FDA UDI 560ae171-c5ad-480b-ab3f-d24ef333987d 33 fields · synced Jun 6, 2026