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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 18 09 12Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- VEGA® RV ABUTMENT ANALOG [CLOSED TRAY] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- VEGA RV ABUTMENT ANALOG [CLOSED TRAY] FDA UDI
- Model / Reference
- 18 09 12 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- VEGA RV ABUTMENT ANALOG [CLOSED TRAY] FDA UDI
Identifiers
- Catalog Number
- 18 09 12 FDA UDI
- Primary DI / UDI-DI
- 08435451646255 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF08QQ EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
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
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
Yes
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: Dental implant suprastructure kit
Klockner by Soadco, S.l. — Class I — 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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- CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class II
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
- CERALOG® PL Abutment straight Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
- evertis — Shinhung MST Co., Ltd. · Class I
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (2)
- FDA UDI b9848218-62f0-4d14-a55e-ac970f5081e5 35 fields · synced Jul 8, 2026
- EUDAMED abe6350a-dc53-4760-8223-c0bb0ad647fb 61 fields · synced Jul 8, 2026