Identity
- Trade Name
- Silkon Plus FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- COSMETIC SILKON TWIN LOWER ANT 018 T-6 A=0 R=0 FDA UDI
- Model / Reference
- 002-2937M FDA UDI
- Description
- COSMETIC SILKON TWIN LOWER ANT 018 T-6 A=0 R=0 FDA UDI
Identifiers
- Catalog Number
- 002-2937M FDA UDI
- Primary DI / UDI-DI
- 00190746002922 FDA UDI
- 510(k) Number
- K891372 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
Yes
FDA UDI
Category: Orthodontic bracket, plastic, single-use
Silkon Plus by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, plastic, single-use.
- ZENITH™ ROTH COMPOSITE BRACKETS (KIT) — G&H Wire Company, Inc. · Class II
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- Carriere® Motion Pro™ — Ortho Organizers, Inc. · Class II
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
- Carriere — Ortho Organizers, Inc. · Class I
- LUCENT™ EDGEWISE METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
Cleared under the same submission
K891372 also covers:
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
- Silkon Plus — American Orthodontics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Orthodontics
Sources (1)
- FDA UDI 1505959c-d37f-4730-837b-a387c47729df 36 fields · synced Jun 9, 2026