Identity
- Trade Name
- MK-dent Germany® FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Model / Reference
- QC4014K FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050546141428 FDA UDI
- 510(k) Number
- K032234 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental handpiece coupler FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pneumatic dental handpiece coupler
MK-dent Germany® by MK-Dent GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental handpiece coupler.
- Airlight — Beyes Dental Canada Inc · Class I
- SABLE Quick Connect — Sable Industries Inc · Class I
- RA-24 Roto Quick 6-Hole — W & H Dentalwerk Bürmoos GmbH · Class I
- Airlight — Beyes Dental Canada Inc · Class I
- Airlight — Beyes Dental Canada Inc · Class I
- DENTALAIRE — Beyes Dental Canada Inc · Class I
- COUPLING MULTIFLEX 4H L — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
Cleared under the same submission
K032234 also covers:
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MK-Dent GmbH
Sources (1)
- FDA UDI 9929e61c-2878-49bc-937d-6130fbc5c442 33 fields · synced May 30, 2026