Identity
- Trade Name
- OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit. FDA UDI
- Model / Reference
- K3 Mount EUDAMEDK3 EUDAMEDFDA UDI
- Description
- A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995045 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800000995045 EUDAMED8800406K3S7 EUDAMED
- 510(k) Number
- K183347 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Italy EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system
K3 Mount by OSSTEM IMPLANT Co., Ltd. Chair Business — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800000995045 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800000995045 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd. Chair Business
- EUDAMED SRN
- KR-MF-000024564
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED f773c676-1536-45d0-a99f-382e6e5a1a9d 61 fields · synced Jul 29, 2026
- FDA UDI 3cb5e408-9fe7-475c-873c-f491a6644740 34 fields · synced May 30, 2026
- EUDAMED 7ded6ce8-630e-42b7-8038-579a6d102384 61 fields · synced Jul 29, 2026