Identity
- Trade Name
- MED610-DSG FDA 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-09193 EUDAMEDMED610-DSG, 1.1 KG 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-09193 FDA UDI
- Primary DI / UDI-DI
- 07290018915042 EUDAMEDFDA 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stratasys Ltd.
- EUDAMED SRN
- IL-MF-000040298
- Authorised Representative
- Stratasys GmbH DE-AR-000039118
Sources (2)
- EUDAMED 9b3bffce-6f86-4f65-847e-22bdcbef64b2 61 fields · synced Jun 17, 2026
- FDA UDI 28931949-ee5f-48a7-8047-7c6067588445 35 fields · synced May 30, 2026