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Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10 14 07Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- EC RETENTIVE CAP EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Overdenture FDA UDI
- Device Name
- EC RETENTIVE CAP FDA UDI
- Model / Reference
- 10 14 07 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- EC RETENTIVE CAP FDA UDI
Identifiers
- Catalog Number
- 10 14 07 FDA UDI
- Primary DI / UDI-DI
- 08435451645258 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF05QJ EUDAMED
- 510(k) Number
- K122988 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Overdenture FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Overdenture
Klockner by Soadco, S.l. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Overdenture.
- Preci-Clix — PREAT Corporation · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
Cleared under the same submission
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
- Soadco, S.l.
Sources (2)
- FDA UDI 8203f321-de32-40de-b9d3-44be00b85b43 36 fields · synced Jun 18, 2026
- EUDAMED e93ca52a-5b9d-42bb-9395-fb36b079742f 61 fields · synced Jun 18, 2026