Identity
- Trade Name
- EZ Bite block FDA UDI
- Generic Name
- Dental suction protective mouthpiece FDA UDI
- Device Name
- Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity • Allows doctors to have an additional hand • Jagged biting surface to minimize slipping • Ideal for keeping upper and lower arch of patient's mouth during oral treatments • Enhances patient's comfort avoiding patient fatigue • Disposable, Single Use Only. Not Autoclavable. FDA UDI
- Model / Reference
- BB-2000L FDA UDI
- Description
- Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity • Allows doctors to have an additional hand • Jagged biting surface to minimize slipping • Ideal for keeping upper and lower arch of patient's mouth during oral treatments • Enhances patient's comfort avoiding patient fatigue • Disposable, Single Use Only. Not Autoclavable. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017901824 FDA UDI
- FDA Product Code
- BRW FDA UDI
- GMDN Term
- Dental suction protective mouthpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental suction protective mouthpiece
EZ Bite block by Dxm Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Isolite Moutpiece — ZYRIS, INC. · Class I
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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
- Dxm Co., Ltd
Sources (1)
- FDA UDI ebd0adff-6c11-4a60-9233-36da343c7235 33 fields · synced Jun 8, 2026