← Back to catalogue
Erkoloc-pro
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 595110Model Erkoloc-proRef 595120
Identity
- Trade Name
- Erkoloc-pro EUDAMEDErkoloc-pro green FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Erkoloc-pro, 1,00 mm, Ø 120 mm, transparent EUDAMEDErkoloc-pro green, 5.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
- Model / Reference
- Erkoloc-pro EUDAMED595110 EUDAMED595120 EUDAMED597450 FDA UDI
- Description
- Erkoloc-pro green, 5.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +ERKO5951101 EUDAMED+ERKO5951201 EUDAMEDERKO5974502 FDA UDI
- Basic UDI-DI
- ++ERKO052aNNNNN1209T8 EUDAMED
- Unit of Use DI
- 1 EUDAMED
- 510(k) Number
- K200125 FDA UDI
- FDA Product Code
- MQC FDA UDIKMY FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 872.5525 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
No
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
Erkoloc-pro by Erkodent Erich Kopp 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++ERKO052aNNNNN1209T8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (3)
- EUDAMED cde1ecb6-1a59-4858-8437-18b6ddddcfe3 61 fields · synced Jul 17, 2026
- EUDAMED 0dc0276d-b3c7-442b-9778-accd2d243901 61 fields · synced May 19, 2026
- FDA UDI b07600d5-75e9-4dde-91ab-47f500392bcc 35 fields · synced May 25, 2026