Identity
- Trade Name
- PRISM™ EDGEWISE COMPOSITE BRACKET (KIT) FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- PRISM™ EDGEWISE .022 KIT W/CASE Prism™ composite brackets. Not only are Prism™ composite brackets nearly invisible, but also the special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. FDA UDI
- Model / Reference
- 47K-EDGE-22-01 FDA UDI
- Description
- PRISM™ EDGEWISE .022 KIT W/CASE Prism™ composite brackets. Not only are Prism™ composite brackets nearly invisible, but also the special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886003152 FDA UDI
- 510(k) Number
- K973776 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
Yes
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
Prism™ Edgewise Composite Bracket (kit) by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, plastic, single-use.
- Silkon Plus — American Orthodontics · Class II
- Carriere® Motion Pro™ — Ortho Organizers, Inc. · Class II
- Silkon Plus — American Orthodontics · Class II
- Carriere — Ortho Organizers, Inc. · Class I
- OrthoFlex — ORTHO TECHNOLOGY, INC. · Class II
- OrthoFlex — ORTHO TECHNOLOGY, INC. · Class II
- Avalon — ORTHO TECHNOLOGY, INC. · Class II
- Silkon Plus — American Orthodontics · Class II
Cleared under the same submission
K973776 also covers:
- COMPOSITE EYELETS — G&H Wire Company, Inc.
- LUCENT™ EDGEWISE METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ ROTH COMPOSITE BRACKET — G&H Wire Company, Inc.
- PRISM™ ROTH COMPOSITE BRACKET — G&H Wire Company, Inc.
- ZENITH™ ROTH COMPOSITE BRACKETS — G&H Wire Company, Inc.
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
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI c3158361-496e-4277-8dfa-3a925ee075a1 35 fields · synced Jun 8, 2026