Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- SELF-FILLING WATER SYRINGE LUER-LOCK FDA UDI
- Model / Reference
- 19.750.00 FDA UDI
- Description
- SELF-FILLING WATER SYRINGE LUER-LOCK FDA UDI
Identifiers
- Catalog Number
- 19.750.00 FDA UDI
- Primary DI / UDI-DI
- EZPF19750000 FDA UDI
- FDA Product Code
- ECB FDA UDI
- GMDN Term
- Dental irrigation/aspiration syringe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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 irrigation/aspiration syringe
Helmut Zepf by Helmut Zepf Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental irrigation/aspiration syringe.
- Vivid HypoJect 3cc — PEARSON DENTAL SUPPLIES, INC. · Class II
- American Eagle Instruments — American Eagle Instruments · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- CLEARJET AIR WATER SYRINGE TIPS 250/bag STD 76mm CLEAR — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- CanalPro — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, 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 |
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Manufacturer
- Manufacturer
- Helmut Zepf Medizintechnik GmbH
Sources (1)
- FDA UDI 3461251b-a8c2-45ea-b3b4-741110d7c700 35 fields · synced May 31, 2026