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Visalys CemCore
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 13576Model Visalys CemCore
Identity
- Trade Name
- Visalys CemCore Dark (A4) Normal pack EUDAMEDVisalys CemCore FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Visalys CemCore EUDAMEDVisalys CemCore Dark (A4) Normal pack 1 x 5 ml + Accessories FDA UDI
- Model / Reference
- 13576 EUDAMEDFDA UDIVisalys CemCore EUDAMED
- Description
- Visalys CemCore Dark (A4) Normal pack 1 x 5 ml + Accessories FDA UDI
Identifiers
- Catalog Number
- 13576 FDA UDI
- Primary DI / UDI-DI
- E217135761 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E217VCCS4 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Visalys CemCore by Kettenbach GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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
- Kettenbach GmbH & Co. KG
Sources (2)
- FDA UDI 778efe37-88ca-4be1-b8be-b2bf36ee8aec 34 fields · synced Oct 7, 2026
- EUDAMED bbad2b4c-52a6-489b-979b-e82598c6bc83 61 fields · synced Oct 7, 2026