Identity
- Trade Name
- Ormco FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- CROWN-PERM LR 2 1ST MOLAR SST PK/5 FDA UDI
- Model / Reference
- 422-0102 FDA UDI
- Description
- CROWN-PERM LR 2 1ST MOLAR SST PK/5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989044317 FDA UDI
- FDA Product Code
- ECM FDA UDI
- GMDN Term
- Orthodontic metal band 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
Category: Orthodontic metal band
Ormco by Ormco Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic metal band.
- Elite — Ortho Organizers, Inc. · Class I
- TruFit 2.0 — ORTHO TECHNOLOGY, INC. · Class I
- dentaform® — Dentaurum · Class I
- Epic — Ortho Organizers, Inc. · Class I
- Band Assemblies — Ortho Organizers, Inc. · Class I
- Tempra — Ortho Organizers, Inc. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- CONLIN MOLAR BANDS — ORTHO ARCH COMPANY 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ormco Corporation
Sources (1)
- FDA UDI ffff0b26-e956-49ca-af2f-a13480225aaa 35 fields · synced Jun 9, 2026