Identity
- Trade Name
- Dental Luxator Elevator FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Dental Luxator Elevator Set Without Tray (10 Each) FDA UDI
- Model / Reference
- 1100-5860-SET FDA UDI
- Description
- Dental Luxator Elevator Set Without Tray (10 Each) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896114470 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
Category: Dental elevator, tooth/root
Dental Luxator Elevator by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental elevator, tooth/root.
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- 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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI e07be7bd-7715-48f0-b87a-f5a9930479da 34 fields · synced Jun 1, 2026