Identity
- Trade Name
- Damon 3 FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- L4R DAMON 3 .022 -12/+2/0 HK FDA UDI
- Model / Reference
- 491-5620 FDA UDI
- Description
- L4R DAMON 3 .022 -12/+2/0 HK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989052794 FDA UDI
- FDA Product Code
- DYW FDA UDI
- GMDN Term
- Orthodontic bracket, plastic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 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
No
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 bracket, plastic, single-use
Damon 3 by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, plastic, single-use.
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- Silkon Plus — American Orthodontics · Class II
- Carriere® Motion Pro™ — Ortho Organizers, Inc. · Class II
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- Silkon Plus — American Orthodontics · Class II
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
Sources (1)
- FDA UDI 31904caa-eb97-481d-a270-bb504bf8be45 35 fields · synced Jun 9, 2026