M5 Restorative Series M5-Sculpt
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- M5 RESTORATIVE SERIES M5-SCULPT EUDAMEDM5 RESTORATIVE SERIES M5-PACK EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- Waxing, M5, Packing, Belvedere, Composite, Spatulas, Hatchets, Scissors EUDAMEDPlugger EUDAMEDM5 Restorative Series M5-Pack FDA UDIM5 Restorative Series M5-Scuplt FDA UDI
- Model / Reference
- M5-SCULPT EUDAMEDFDA UDIM5-PACK EUDAMEDFDA UDI
- Description
- M5 Restorative Series M5-Pack FDA UDIM5 Restorative Series M5-Scuplt FDA UDI
Identifiers
- Catalog Number
- M5-PACK FDA UDIM5-SCULPT FDA UDI
- Primary DI / UDI-DI
- 00841013119729 EUDAMEDFDA UDI00841013119699 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013138530EIYD153981HX EUDAMED0841013141876EKRA737882NH EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental spatula, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Belgium EUDAMEDIreland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
M5 Restorative Series M5-Sculpt by American Eagle Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0841013138530EIYD153981HX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (4)
- EUDAMED d1331bc0-724f-4582-9355-e601f01a4778 61 fields · synced Aug 4, 2026
- EUDAMED 130a9215-54f3-4172-bd63-91d25b3518d6 61 fields · synced May 18, 2026
- FDA UDI a974ae81-b67a-445c-849d-4f53590a53aa 35 fields · synced May 30, 2026
- FDA UDI 436a1c62-9df6-43a8-9d6b-f1c640fcfd31 35 fields · synced May 30, 2026