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Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 82 12 01 GModel Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- HEXAGONAL CASTABLE ABUTMENT Ø5.5MM SET [HEXAGONAL SCREW] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- HEXAGONAL CASTABLE ABUTMENT Ø5.5MM SET [HEXAGONAL SCREW] FDA UDI
- Model / Reference
- 82 12 01 G EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- HEXAGONAL CASTABLE ABUTMENT Ø5.5MM SET [HEXAGONAL SCREW] FDA UDI
Identifiers
- Catalog Number
- 82 12 01 G FDA UDI
- Primary DI / UDI-DI
- 08435451650573 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF99RM EUDAMED
- 510(k) Number
- K010132 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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: 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
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 578aa4b0-a318-4bf6-9cdd-cfaa1503c0f1 36 fields · synced Jul 30, 2026
- EUDAMED 8b47474b-9068-40f4-a8df-e79e4c06926e 61 fields · synced Jul 30, 2026