← Back to catalogue
Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8530Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- SK2 M1.6MM ABUTMENT ANALOG SCREW EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- SK2 M1.6MM ABUTMENT ANALOG SCREW FDA UDI
- Model / Reference
- 8530 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- SK2 M1.6MM ABUTMENT ANALOG SCREW FDA UDI
Identifiers
- Catalog Number
- 8530 FDA UDI
- Primary DI / UDI-DI
- 08435451654717 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF08QQ EUDAMED
- 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 I 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
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 II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure kit.
- ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) — CeramTec Schweiz GmbH · Class II
- 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (2)
- FDA UDI 181dbafb-0925-4a8f-a9d4-1b998289dd2d 35 fields · synced Jun 20, 2026
- EUDAMED 44e4d381-fab4-4e87-b651-0ff0dec7ed18 61 fields · synced Jun 20, 2026