Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- VEGA® NV TIBASE ABUTMENT [U-AT1.5-AP5] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- VEGA NV Ti-BASE ABUTMENT [U-AT1.5-AP5] FDA UDI
- Model / Reference
- 18 10 25 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- VEGA NV Ti-BASE ABUTMENT [U-AT1.5-AP5] FDA UDI
Identifiers
- Catalog Number
- 18 10 25 FDA UDI
- Primary DI / UDI-DI
- 08435451646552 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF03QE EUDAMED
- 510(k) Number
- K170022 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class IIb 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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 implant suprastructure kit
Klockner by Soadco, S.l. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure kit.
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- evertis — Shinhung MST Co., Ltd. · Class I
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II
Cleared under the same submission
K170022 also covers:
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 68839694-cda7-48ab-b477-8e86120dfb33 36 fields · synced Jul 30, 2026
- EUDAMED 86f50d27-8ac2-4997-8676-d59d497e81ca 61 fields · synced Jul 30, 2026