Identity
- Trade Name
- Gutta Percha Points EUDAMED
- Device Name
- Accessory Gutta Percha Points EUDAMED
- Model / Reference
- 972-1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055165036144 EUDAMED
- Basic UDI-DI
- 80515118720000025D EUDAMED
- EMDN Code
- Q01010203 DENTAL CONES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Synthetic gutta-percha
Gutta Percha Points by Kerr Italia Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Synthetic gutta-percha.
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- Gutta Percha Points — TULSA DENTAL PRODUCTS LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80515118720000025D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kerr Italia Srl
- EUDAMED SRN
- IT-MF-000007768
Sources (1)
- EUDAMED e9f961a4-0615-41f5-942a-8fbee9eb30c0 61 fields · synced Jun 19, 2026