Identity
- Trade Name
- IPS InLine Sy Powder Opaquer 18g D3 EUDAMEDIPS InLine FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- IPS InLine EUDAMEDIPS InLine Sy Powder Opaquer 18g D3 FDA UDI
- Model / Reference
- 649185 EUDAMEDFDA UDI
- Description
- IPS InLine Sy Powder Opaquer 18g D3 FDA UDI
Identifiers
- Catalog Number
- 649185 FDA UDI
- Primary DI / UDI-DI
- 07615208350883 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACERA011ET EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, ceramic
IPS InLine by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI bddb1a90-b4f3-4205-b597-4c68e7d587ac 34 fields · synced Jul 29, 2026
- EUDAMED 6b734bec-ddb5-48cd-9585-e5a3bb11dcda 61 fields · synced Jul 29, 2026