Identity
- Trade Name
- Erkoloc-pro FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Erkoloc-pro, 5.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
- Model / Reference
- 595350 FDA UDI
- Description
- Erkoloc-pro, 5.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ERKO5953503 FDA UDI
- 510(k) Number
- K200125 FDA UDI
- FDA Product Code
- MQC FDA UDIKMY FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 appliance fabrication material, thermoplastic
Erkoloc-pro by Erkodent Erich Kopp GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, thermoplastic.
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- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
Cleared under the same submission
K200125 also covers:
- Erkodur — Erkodent Erich Kopp GmbH
- Erkodur — Erkodent Erich Kopp GmbH
- Erkodur — Erkodent Erich Kopp GmbH
- Erkodur freeze — Erkodent Erich Kopp GmbH
- Erkodur freeze — Erkodent Erich Kopp GmbH
- Erkodur freeze — Erkodent Erich Kopp GmbH
- Erkodur freeze — Erkodent Erich Kopp GmbH
- Erkodur freeze — Erkodent Erich Kopp GmbH
- Erkodur-0M1 — Erkodent Erich Kopp GmbH
- Erkodur-0M1 — Erkodent Erich Kopp GmbH
- Erkodur-A1 — Erkodent Erich Kopp GmbH
- Erkodur-A3 — Erkodent Erich Kopp GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
Sources (1)
- FDA UDI d973314a-9734-4ca8-90a4-d2d6b1d96a7b 35 fields · synced May 30, 2026