Identity
- Trade Name
- IPS e.max Press Multi BL2 5 pcs. EUDAMEDIPS e.max Press FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- IPS e.max Press EUDAMEDIPS e.max Press Multi BL2 5 pcs. FDA UDI
- Model / Reference
- 638638 EUDAMEDFDA UDI
- Description
- IPS e.max Press Multi BL2 5 pcs. FDA UDI
Identifiers
- Catalog Number
- 638638 FDA UDI
- Primary DI / UDI-DI
- 07615208360769 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082BABUT003JC EUDAMED
- Unit of Use DI
- 07615208512373 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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 implant suprastructure, permanent, preformed
IPS e.max Press 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
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 |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI b3eaeaba-75de-460f-b718-9ac2c9e9095c 34 fields · synced Oct 8, 2026
- EUDAMED 4c4f190d-a2a2-4f1a-8175-f775d372ffbc 61 fields · synced Oct 8, 2026