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Sterile Dental Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref API-08500Model Advanced Precision Implant (API)
Identity
- Trade Name
- Sterile Dental Implant EUDAMEDDitron Dental FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Advanced Precision Implant Ø5mm L8mm EUDAMEDAdvanced Precision Implant Ø5.0mm L8mm FDA UDI
- Model / Reference
- Advanced Precision Implant (API) EUDAMEDAPI-08500 EUDAMEDFDA UDI
- Description
- Advanced Precision Implant Ø5.0mm L8mm FDA UDI
Identifiers
- Catalog Number
- API-08500 FDA UDI
- Primary DI / UDI-DI
- 07290109280820 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290109280820 EUDAMED
- 510(k) Number
- K161497 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Sterile Dental Implant by Ditron Dental Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290109280820 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd.
- EUDAMED SRN
- IL-MF-000015966
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED b7400997-25d7-4497-b010-f245ece52b34 61 fields · synced Jun 18, 2026
- FDA UDI 6a6ff8b6-549a-454c-9304-81504861e344 36 fields · synced May 30, 2026