Identity
- Trade Name
- Miniscope Telescoping Herbst FDA UDI
- Generic Name
- Orthodontic rod-based aligner FDA UDI
- Device Name
- MINISCOPE TELESCOPING MECHANISM 21MM LEFT FDA UDI
- Model / Reference
- 855-921L FDA UDI
- Description
- MINISCOPE TELESCOPING MECHANISM 21MM LEFT FDA UDI
Identifiers
- Catalog Number
- 855-921L FDA UDI
- Primary DI / UDI-DI
- 00190746076336 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
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic rod-based aligner
Miniscope Telescoping Herbst by American Orthodontics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Flip-Lock Herbst Appliance — TP ORTHODONTICS, INC. · Class I
- Flip-Lock Herbst Appliance — TP ORTHODONTICS, INC. · Class I
- Cantilever Herbst — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Mara Appliance — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Flip-Lock Herbst Appliance — TP ORTHODONTICS, INC. · Class I
- Flip-Lock Herbst Appliance — TP ORTHODONTICS, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Orthodontics
Sources (2)
- FDA UDI 0b13079b-0d65-4161-95d2-6f8f58ffcca8 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026