Klockner
FDA UDIEUDAMEDClass II (US FDA UDI)
by Soadco, S.l.
Identity
- Trade Name
- EXPANDER KIT EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- EXPANDER BOX KIT FDA UDI
- Model / Reference
- KIT 10 00 03 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- EXPANDER BOX KIT FDA UDI
Identifiers
- Catalog Number
- KIT 10 00 03 FDA UDI
- Primary DI / UDI-DI
- 08435451630629 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF18QT EUDAMED
- 510(k) Number
- K173642 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, 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
Yes
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: Fixture/appliance dental drill bit, 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 Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
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 6c63ef5e-4d0a-40d6-9bf3-006d266b5113 36 fields · synced Jul 18, 2026
- EUDAMED 92203f92-9193-46c4-8c09-537d05b12577 61 fields · synced Jul 18, 2026