Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- SYRINGE, CARTRIDGE BREECH LOADING SYSTEM, WITH 3 ASPIRAT. WITH 3 ASPIRATION HOOKS , 1.8 ML FDA UDI
- Model / Reference
- 19.710.18 FDA UDI
- Description
- SYRINGE, CARTRIDGE BREECH LOADING SYSTEM, WITH 3 ASPIRAT. WITH 3 ASPIRATION HOOKS , 1.8 ML FDA UDI
Identifiers
- Catalog Number
- 19.710.18 FDA UDI
- Primary DI / UDI-DI
- EZPF19710180 FDA UDI
- FDA Product Code
- ECB FDA UDI
- GMDN Term
- Dental anaesthesia syringe, reusable 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 anaesthesia syringe, reusable
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 anaesthesia syringe, reusable.
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- Henry Schein — HENRY SCHEIN, INC. · Class II
- Dentapen Injector — JUVAPLUS SA · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
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 dff1a137-8ea9-4edf-90d9-c7621e5aac07 35 fields · synced May 30, 2026