Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Root Tip Pick HeidBrink 13/14 FDA UDI
- Model / Reference
- SD3906 FDA UDI
- Description
- Root Tip Pick HeidBrink 13/14 FDA UDI
Identifiers
- Catalog Number
- SD3906 FDA UDI
- Primary DI / UDI-DI
- B382SD39060 FDA UDI
- FDA Product Code
- EIX 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
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
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
Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental elevator, tooth/root.
- ROOT ELEVATOR HEIDBRINK #3 EH-LG S/E — W.H. Holden, Inc. · Class I
- ELEVATOR #107 — W.H. Holden, Inc. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Paul Banditt — Terlain Enterprises, 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 1b9ed236-73e0-4107-ba78-6dfac18fa579 35 fields · synced Jun 6, 2026