IRIS™, RS Snap-on Impression Kit, RH 4mm GH 3mm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- IRIS™, RS Snap-on Impression Kit, RH 4mm GH 3mm EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Model / Reference
- Kit EUDAMEDIR4143 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109301518 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010930IRISSnapOnImpAF EUDAMED
- 510(k) Number
- K081751 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
IRIS™, RS Snap-on Impression Kit, RH 4mm GH 3mm by Adin Dental Implant Systems Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010930IRISSnapOnImpAF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED c27d1481-5ce7-4fb1-af85-a8ab646842b8 61 fields · synced Jul 12, 2026
- FDA UDI 1aff4f77-5c04-4449-9a29-50f24a5424ee 33 fields · synced May 30, 2026