Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- PTERIGOMAXILAR KIT EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- PTERIGOMAXILAR BOX KIT FDA UDI
- Model / Reference
- KIT 10 00 06 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- PTERIGOMAXILAR BOX KIT FDA UDI
Identifiers
- Catalog Number
- KIT 10 00 06 FDA UDI
- Primary DI / UDI-DI
- 08435451635426 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF23N2H2 EUDAMED
- 510(k) Number
- K173642 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Klockner by Soadco, S.l. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 36fdf852-afd3-477c-8889-58983a51228a 36 fields · synced Jun 19, 2026
- EUDAMED 9bfcd3b6-7952-4350-94c8-675edf7d299f 61 fields · synced Jun 19, 2026