Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Dental suction protective mouthpiece FDA UDI
- Device Name
- ACCLEAN Hands-free HVE Hose Accessory Kit (2 long hoses, 4 short hoses with adapters) FDA UDI
- Model / Reference
- 5703900 FDA UDI
- Description
- ACCLEAN Hands-free HVE Hose Accessory Kit (2 long hoses, 4 short hoses with adapters) FDA UDI
Identifiers
- Catalog Number
- 5703900 FDA UDI
- Primary DI / UDI-DI
- 00304040186503 FDA UDI
- FDA Product Code
- EHZ FDA UDI
- GMDN Term
- Dental suction protective mouthpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental suction protective mouthpiece
Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental suction protective mouthpiece.
- EZ Bite block — DXM CO., LTD · Class I
- Isolite Mouthpiece — ZYRIS, INC. · Class I
- Isolite Moutpiece — ZYRIS, INC. · Class I
- Anterior Mouthpiece — ZYRIS, INC. · Class I
- Isolite Moutpiece — ZYRIS, INC. · Class I
- Anterior Mouthpiece — ZYRIS, INC. · Class I
- Isolite Moutpiece — ZYRIS, INC. · Class I
- Isolite Moutpiece — ZYRIS, INC. · Class I
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 67e6dcde-b510-4640-b649-872525f96b31 34 fields · synced May 30, 2026