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Adin Regular Long Drill Stop Kit
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref S1001Model Kit510(k) K252031
Identity
- Trade Name
- Adin Regular Long Drill Stop Kit EUDAMEDFDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Model / Reference
- Kit EUDAMEDS1001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290105156938 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010515FullKitHE EUDAMED
- FDA Product Code
- OFY FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Adin Regular Long Drill Stop Kit by Adin Dental Implant Systems Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252031 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729010515FullKitHE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- FDA Applicant
- Adin Dental Implant Systems , Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 51146119-94d2-4416-9464-f201815ab125 85 fields · synced Jun 18, 2026
- FDA UDI f7563f2f-cf1c-4194-a549-4b5d6e1cac2a 32 fields · synced May 30, 2026
- FDA 510(k) K252031 1 fields · synced May 18, 2026