Identity
- Trade Name
- GoldenDent FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- GMX Lingual Elevator FDA UDI
- Model / Reference
- GMX LE FDA UDI
- Description
- GMX Lingual Elevator FDA UDI
Identifiers
- Catalog Number
- GMX LE FDA UDI
- Primary DI / UDI-DI
- 00850011211595 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental elevator, tooth/root
GoldenDent by GoldenDent — 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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- 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
- GoldenDent
Sources (1)
- FDA UDI 47b11352-1a22-4858-9120-d94303e09770 34 fields · synced May 30, 2026