Identity
- Trade Name
- M-D Reducer FDA UDI
- Generic Name
- Orthodontic palate expander/teeth aligner, bonded FDA UDI
- Device Name
- INSTRUMENTS, DENTAL HAND FDA UDI
- Model / Reference
- 100-700 FDA UDI
- Description
- INSTRUMENTS, DENTAL HAND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029043202 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Orthodontic palate expander/teeth aligner, bonded 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
No
FDA UDI
Category: Orthodontic palate expander/teeth aligner, bonded
M-D Reducer by Tp Orthodontics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic palate expander/teeth aligner, bonded.
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- Distal Jet Set Screw, Pk/10 — ALLESEE AOA-PRO · Class I
- FS-AG-Sagittal — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- ATOZ Expander Kit — M.K. Meditech Co. , Ltd. · Class I
- FS 3-Way w/Memory Gear — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, 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
- Tp Orthodontics, Inc.
Sources (1)
- FDA UDI 2185c893-946b-4773-884d-6970180075b7 34 fields · synced May 30, 2026