Identity
- Trade Name
- Pre-Finisher FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Non-Extraction w/Seating Springs FDA UDI
- Model / Reference
- 190-147 FDA UDI
- Description
- Non-Extraction w/Seating Springs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029041703 FDA UDI
- 510(k) Number
- K780619 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic retainer
Pre-Finisher by Tp Orthodontics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
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- Stainless Steel Spring — American Orthodontics · Class IIa
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
Cleared under the same submission
K780619 also covers:
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
- Pre-Finisher — TP ORTHODONTICS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tp Orthodontics, Inc.
Sources (1)
- FDA UDI 8addd6ec-0b57-4eb2-9ffe-82e907a546d5 34 fields · synced May 30, 2026