Identity
- Trade Name
- EZ-Swivel EUDAMEDFDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- Quick Coupler EUDAMEDEZ-Swivel QD B2, 2 Holes FDA UDI
- Model / Reference
- HP3018 EUDAMEDHP3019 EUDAMEDFDA UDI
- Description
- EZ-Swivel QD B2, 2 Holes FDA UDI
Identifiers
- Catalog Number
- EZ-Swivel QD B2 FDA UDI
- Primary DI / UDI-DI
- 00990010301481 EUDAMEDFDA UDI
- Basic UDI-DI
- 99001030147492 EUDAMED
- Direct Marketing DI
- 00990010301481 EUDAMED
- 510(k) Number
- K101551 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pneumatic dental handpiece coupler FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
EZ-Swivel by Beyes Dental Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 99001030147492 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beyes Dental Inc
- EUDAMED SRN
- CA-MF-000001491
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED de7010fe-b74e-4e02-b6e0-e567799cac52 61 fields · synced Jul 19, 2026
- FDA UDI a1b2cb83-6653-43c0-a98b-f091a71c8c94 35 fields · synced May 30, 2026