Identity
- Trade Name
- Beyes FDA UDI
- Generic Name
- Dental abrasive air jet system handpiece FDA UDI
- Device Name
- easyProphy 200/QD EasyProphy Air Polishing System FDA UDI
- Model / Reference
- EP3003 FDA UDI
- Description
- easyProphy 200/QD EasyProphy Air Polishing System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00837699001168 FDA UDI
- 510(k) Number
- K112869 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental abrasive air jet system handpiece 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Dental abrasive air jet system handpiece
Beyes by Beyes Dental Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112869 also covers:
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 |
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Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
Sources (1)
- FDA UDI 0766a431-91ab-436b-8d6e-f6758daff396 34 fields · synced May 30, 2026