Identity
- Trade Name
- EZ-Swivel FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- EZ-Swivel K E6, 6 Holes FDA UDI
- Model / Reference
- HP2064 FDA UDI
- Description
- EZ-Swivel K E6, 6 Holes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00837699000239 FDA UDI
- 510(k) Number
- K101551 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
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
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
EZ-Swivel by Beyes Dental Canada Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental handpiece coupler.
- SABLE Quick Connect — Sable Industries Inc · Class I
- MK-dent — MK-Dent GmbH · Class I
- RA-24 Roto Quick 6-Hole — W & H Dentalwerk Bürmoos GmbH · Class I
- MK-dent Germany® — MK-Dent GmbH · Class I
- COUPLING MULTIFLEX 4H L — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
- SABLE - Kavo Multiflex — Sable Industries Inc · Class I
- Johnson-Promident — Young Innovations, Inc. · Class I
Cleared under the same submission
K101551 also covers:
- Airlight — Beyes Dental Canada Inc
- EZ-Swivel — Beyes Dental Canada Inc
- EZ-Swivel — Beyes Dental Canada Inc
- EZ-Swivel — Beyes Dental Canada Inc
- EZ-Swivel — Beyes Dental Canada Inc
- EZ-Swivel — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
- MAXSO — Beyes Dental Canada Inc
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
Sources (2)
- FDA UDI b5167358-496e-4f0a-972f-0dbb1dc1cc75 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026