Identity
- Trade Name
- Dental Instrument EUDAMEDLab Analog(Ball type) EUDAMEDMini Plus Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- Lab Analog(Ball type) EUDAMEDCOWELL® Reusable Surgical Instrument EUDAMED
- Model / Reference
- AMBL001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471729739 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809471729739 EUDAMED880947172M01RED04T07XX EUDAMED
- 510(k) Number
- K090049 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental Instrument by Cowellmedi Co., Ltd — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08809471729739 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08809471729739 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000009689
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 2472b1e1-c4bb-44ea-b585-d640b122c23d 61 fields · synced Jun 14, 2026
- FDA UDI 93d48d2c-60f2-4acd-9159-71dadbd8159d 33 fields · synced May 30, 2026
- EUDAMED 6b5f9a3a-6bde-49ee-b37d-dfac4c211b45 61 fields · synced Jun 14, 2026