Identity
- Trade Name
- Light Wire Pliers FDA UDI
- Generic Name
- Orthodontic pliers FDA UDI
- Device Name
- Instruments EUDAMEDThree Grooves FDA UDI
- Model / Reference
- 100-125 EUDAMEDFDA UDI
- Description
- Three Grooves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029042946 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192029InstrumentsKB EUDAMED
- FDA Product Code
- JEX FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic pliers FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Instruments by Tp Orthodontics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0192029InstrumentsKB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TP Orthodontics, Inc.
- EUDAMED SRN
- US-MF-000020559
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a5fe2e10-9521-4c04-84cf-b839ceca9a85 61 fields · synced Jun 18, 2026
- FDA UDI bc18063a-97ea-4316-bfdd-f8fd2aa36423 33 fields · synced May 29, 2026