← Back to catalogue

Celtra Press Starter Kit

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 5365400113Model Ceramics Procedure Pack

by DeguDent GmbH

Identity

Trade Name
Celtra Press Starter Kit EUDAMED
Celtra ® FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Model / Reference
Ceramics Procedure Pack EUDAMED
5365400113 EUDAMED
CELTRA PRESS Starter Kit FDA UDI

Identifiers

Catalog Number
5365400113 FDA UDI
Primary DI / UDI-DI
+EDD153654001130 EUDAMED
EDD153654001130 FDA UDI
Basic UDI-DI
++EDD1PPCERAMICSYG EUDAMED
FDA Product Code
EIH FDA UDI
EMDN Code
Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Medical Purpose
This procedure packs are intended to be used for fixed dental prosthetic restorations. EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Celtra Press Starter Kit by DeguDent GmbH — Class IIa — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DeguDent GmbH
EUDAMED SRN
DE-PR-000034763

Sources (2)

  • EUDAMED d89a5aac-7aed-4e92-a77a-ae7431591021 61 fields · synced Jul 29, 2026
  • FDA UDI 183d766c-ce35-4018-aa06-aaba8ee7f680 36 fields · synced May 30, 2026