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MED610-DSG™ Biocompatible Clear
EUDAMEDFDA UDIClass I (EU MDR)
Ref OBJ-03385Ref OBJ-04078Ref OBJ-12067Ref OBJ-18261
Identity
- Trade Name
- MED610-DSG EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- MED610-DSG™ Biocompatible Clear EUDAMEDMED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants. FDA UDI
- Model / Reference
- OBJ-03385 EUDAMEDOBJ-04078 EUDAMEDOBJ-12067 EUDAMEDOBJ-18261 EUDAMEDMED610-DSG, 3.6 KG FDA UDIMED610-DSG, 1KG FDA UDIMED610-DSG, 4KG (J5DentaJet) FDA UDIMED610-DSG, 4KG FDA UDI
- Description
- MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants. FDA UDI
Identifiers
- Catalog Number
- OBJ-03385 FDA UDIOBJ-04078 FDA UDIOBJ-12067 FDA UDIOBJ-18261 FDA UDI
- Primary DI / UDI-DI
- 07290018915240 EUDAMEDFDA UDI07290018915837 EUDAMED07290018915646 EUDAMEDFDA UDI07290018915448 EUDAMEDFDA UDI07290018915844 FDA UDI
- Basic UDI-DI
- 7290018915MED610DSGUP EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MED610-DSG™ Biocompatible Clear by Stratasys Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290018915MED610DSGUP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stratasys Ltd.
- EUDAMED SRN
- IL-MF-000040298
- Authorised Representative
- Stratasys GmbH DE-AR-000039118
Sources (12)
- EUDAMED 7e5b6ee2-8196-49a5-ab2f-060e9682d32f 61 fields · synced Jul 31, 2026
- EUDAMED 6d6a1518-205e-4e12-b4d5-6394a17efe6c 61 fields · synced May 17, 2026
- EUDAMED fd019763-6f20-403c-a23b-e5ad3f4f42d9 61 fields · synced May 18, 2026
- EUDAMED ff21b0cf-79c2-4813-817e-20cd0d292d14 61 fields · synced May 18, 2026
- FDA UDI 3ac3555d-1116-4641-9c4d-82af9d118e5b 35 fields · synced May 24, 2026
- FDA UDI 30160fb9-d2ee-4f18-ba04-c2ead60dbfa8 35 fields · synced May 30, 2026
- FDA UDI 1a39fcd4-0403-4fff-8a09-4539891f6f5c 35 fields · synced May 30, 2026
- FDA UDI 61fd17d3-eb42-412a-9ad5-c84bac4e4349 35 fields · synced May 30, 2026
- EUDAMED fa3dad80-bb4a-4b0f-a6f7-658ff341dda0 61 fields · synced Jul 10, 2026
- EUDAMED d15f1a68-35a3-4a77-b0d2-45bf01ec8fb5 61 fields · synced Jul 11, 2026
- EUDAMED aa2c26a5-177a-4186-9e19-2a9c14eeee21 61 fields · synced Jul 12, 2026
- EUDAMED ebd19530-3839-4c43-87a7-870cb8e22864 61 fields · synced Jul 31, 2026