RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills EUDAMEDStandard Internal Hex Plastic Surgical Kit-Advanced EUDAMEDStandard Internal Hex Plastic Surgical Kit-Advanced Short Drills EUDAMEDRS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- Tools EUDAMED
- Model / Reference
- Kit EUDAMEDRS6324 EUDAMEDFDA UDITools EUDAMEDSURPA EUDAMEDSURPAS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290105156372 EUDAMEDFDA UDID-DEMF000009412SURPABT EUDAMED04260525162829 EUDAMED
- Basic UDI-DI
- 729010515FullKitHE EUDAMEDB-DEMF000009412SURPABT EUDAMED426052516FullKitFK EUDAMED
- FDA Product Code
- OFY FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMEDZ12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES 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 EUDAMEDTürkiye 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills by Adin Dental Implant Systems Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED…
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 729010515FullKitHE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729010515FullKitHE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 8a06e65b-672f-4ff3-9a86-37a783f2f3c6 61 fields · synced Jul 28, 2026
- EUDAMED 78152b68-9300-4a35-b17f-96e78ba0e6e8 61 fields · synced May 19, 2026
- EUDAMED c33ffaaf-05e9-402b-92bd-2aaed880e88b 61 fields · synced May 19, 2026
- FDA UDI ba34581d-0182-4f0a-b2a3-5dc2faeabc0c 32 fields · synced May 29, 2026