Simple Mount
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Simple Mount EUDAMEDFDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDIDental power tool endpiece inserter/remover FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ISFM600 EUDAMEDFDA UDIISFM480 EUDAMEDFDA UDISSSWB EUDAMEDSSSRG EUDAMEDESFMW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809892357894 EUDAMEDFDA UDI08809892357887 EUDAMEDFDA UDI08809892369774 EUDAMED08809892369767 EUDAMED08800000933351 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDIDental power tool endpiece inserter/remover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant holding endpiece, reusable
Simple Mount by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (7)
- FDA UDI 829c63aa-2f29-48e3-8170-796b0e2f5c82 32 fields · synced Jul 26, 2026
- FDA UDI 57ab8561-de3d-4fc7-90b8-79f66423682d 32 fields · synced May 30, 2026
- FDA UDI 113bd0eb-562e-4a0e-96c9-b71cc8b8c04c 32 fields · synced May 30, 2026
- EUDAMED dd2f1391-2b0b-4ca6-bd64-b9c3a5fa4d8c 61 fields · synced Jul 9, 2026
- EUDAMED 129f7e10-fa66-40e3-983e-3a6c8fa49cff 61 fields · synced Jul 22, 2026
- EUDAMED a399ce11-80dd-4afd-9108-170400220133 61 fields · synced Jul 25, 2026
- EUDAMED 1b707dfe-1820-48c5-91bc-1170bcfb29cb 61 fields · synced Jul 26, 2026