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P Pro Surgical Guide Clear
EUDAMEDFDA UDIClass I (EU MDR)
Ref 019.3043Model Light curing resins for generative manufacturing of dental drill guides
Identity
- Trade Name
- P Pro Surgical Guide Clear EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- P pro Surgical Guide Clear 1000g FDA UDI
- Model / Reference
- Light curing resins for generative manufacturing of dental drill guides EUDAMED019.3043 EUDAMEDFDA UDI
- Description
- P pro Surgical Guide Clear 1000g FDA UDI
Identifiers
- Catalog Number
- 019.3043 FDA UDI
- Primary DI / UDI-DI
- 04260635980146 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EDELTD11BUDI010028FC EUDAMED
- Direct Marketing DI
- 04260635980146 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL 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
Yes
FDA UDI
P Pro Surgical Guide Clear by DeltaMed GmbH — 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 | ++EDELTD11BUDI010028FC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED 650f160b-1e6a-4ed0-9df6-1409e948e3c5 61 fields · synced Jul 9, 2026
- FDA UDI b20c9c80-cdda-4e37-973d-905c7974221d 35 fields · synced May 30, 2026