Identity
- Trade Name
- IPS e.max Ceram Dentin 100 g A1 EUDAMEDIPS e.max Ceram FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- IPS e.max Ceram EUDAMEDIPS e.max Ceram Dentin 100 g A1 FDA UDI
- Model / Reference
- 605497 EUDAMEDFDA UDI
- Description
- IPS e.max Ceram Dentin 100 g A1 FDA UDI
Identifiers
- Catalog Number
- 605497 FDA UDI
- Primary DI / UDI-DI
- 07615208374049 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACERA008F6 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
Single Use
No
Implantable
Yes
Reusable
No
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
IPS e.max Ceram by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI baccd87d-604d-4437-9532-818075afd68a 34 fields · synced Jul 14, 2026
- EUDAMED c1b34f3f-e189-423b-b427-7cc884c19657 61 fields · synced Jul 14, 2026