Identity
- Trade Name
- Flip-Lock Herbst Appliance FDA UDI
- Generic Name
- Orthodontic rod-based aligner FDA UDI
- Device Name
- FlipLock Herbst Parts FDA UDI
- Model / Reference
- 610-430 FDA UDI
- Description
- FlipLock Herbst Parts FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029048467 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic rod-based aligner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
Yes
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 rod-based aligner
Flip-Lock Herbst Appliance by Tp Orthodontics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic rod-based aligner.
- 4-Part Telescoping Herbst Replacement Parts — SPECIALTY APPLIANCES, LLC · Class I
- HTH®-Right 24mm — SPECIALTY APPLIANCES, LLC · Class I
- Cantilever Herbst — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Mara Appliance — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Flip-Lock® Rod-Lower — SPECIALTY APPLIANCES, LLC · Class I
- MiniScope-Left 27mm — SPECIALTY APPLIANCES, LLC · Class I
- HTH®-Right 21mm — SPECIALTY APPLIANCES, LLC · Class I
- M4-Right 19mm — SPECIALTY APPLIANCES, LLC · 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 1c26e41d-eb91-49a9-a687-4b71b1171404 34 fields · synced Jun 8, 2026