Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- ROOT ELEVATOR, WINTER, LEFT, FIG. 1-R FDA UDI
- Model / Reference
- 17.335.16 FDA UDI
- Description
- ROOT ELEVATOR, WINTER, LEFT, FIG. 1-R FDA UDI
Identifiers
- Catalog Number
- 17.335.16 FDA UDI
- Primary DI / UDI-DI
- EZPF17335160 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Dental elevator, tooth/root 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 elevator, tooth/root
Helmut Zepf by Helmut Zepf Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental elevator, tooth/root.
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- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
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- Paul Banditt — Terlain Enterprises, Inc. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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 d86fbc7b-d0a7-4f74-8f04-25009d7cfd9a 35 fields · synced May 30, 2026