Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- PROSTHETIC BOX [EMPTY] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- PROSTHETIC BOX [EMPTY] FDA UDI
- Model / Reference
- 10 00 08 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- PROSTHETIC BOX [EMPTY] FDA UDI
Identifiers
- Catalog Number
- 10 00 08 FDA UDI
- Primary DI / UDI-DI
- 08435451695116 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF19QV EUDAMED
- 510(k) Number
- K173642 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
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
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
- UniFit-Standard Internal Star Plastic Surgical Kit-Advanced — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (2)
- FDA UDI 3271ce12-174f-4527-a604-2b7b6549f811 36 fields · synced Jul 8, 2026
- EUDAMED 4760b8ab-d423-49be-8250-4acbbd753f69 61 fields · synced Jun 18, 2026