Identity
- Trade Name
- Pre-Finisher FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- PreFinishers EUDAMEDNon-Extraction FDA UDI
- Model / Reference
- 190-044 EUDAMEDFDA UDI
- Description
- Non-Extraction FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029041468 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192029PreFinishers7H EUDAMED
- 510(k) Number
- K780619 FDA UDI
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PreFinishers 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 | 0192029PreFinishers7H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TP Orthodontics, Inc.
- EUDAMED SRN
- US-MF-000020559
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 626f3c75-7e51-4409-9233-f122ab1d37bb 61 fields · synced Jul 10, 2026
- FDA UDI 8c46cc61-e6be-48aa-a2e8-c39fe9e2f2e1 34 fields · synced May 30, 2026