Osstem Implant Co., Ltd. Chair Business
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments. FDA UDI
- Model / Reference
- K5 EUDAMEDFDA UDIK5 Cart EUDAMED
- Description
- The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995977 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800406K5SB EUDAMED
- FDA Product Code
- EIA FDA UDIKLC 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 UDI872.6250 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental delivery system
Osstem Implant Co., Ltd. Chair Business by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
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- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
Cleared under the same submission
K233805 also covers:
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 (2)
- FDA UDI 650a1130-eab5-4b0d-a43c-3ef7d325e78f 34 fields · synced Jul 16, 2026
- EUDAMED d211e76f-71f2-4c9a-9bdf-204e898bad75 61 fields · synced Jul 16, 2026