GUDIDData
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eudamed_udi Primary ID: 07615208368543

IPS e.max Press LT C1 5 pcs (UDI 07615208368543)

Manufactured by Ivoclar Vivadent AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IPS e.max Press LT C1 5 pcs - Primary ID 07615208368543

Device Regulatory Overview

The IPS e.max Press LT C1 5 pcs (Model/Catalog Number: 626308) is a medical device manufactured by Ivoclar Vivadent AG. This product is indexed under FDA Product Code / Category Classification P01020101 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1840-2020 View Full Alert →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1838-2020 View Full Alert →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-st...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1839-2020 View Full Alert →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-s...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
626308
Product Code / EMDN
P01020101
Device Name
IPS e.max Press
Database Sync Date
2026-08-09 16:28:47

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of IPS e.max Press LT C1 5 pcs?

The registered manufacturer of record for IPS e.max Press LT C1 5 pcs is Ivoclar Vivadent AG.

What is the Primary UDI-DI identifier for IPS e.max Press LT C1 5 pcs?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07615208368543.

What classification code is assigned to this device?

This device is registered under product classification code P01020101.

Similar Classification Devices (P01020101)

Other Devices by Ivoclar Vivadent AG

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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