Identity
- Trade Name
- ZENITH™ ROTH COMPOSITE BRACKETS (KIT) FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- ZENITH™ ROTH COMP 5-5 3,4,5 KIT 022 W/HKS Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more. FDA UDI
- Model / Reference
- KTRCM2355P FDA UDI
- Description
- ZENITH™ ROTH COMP 5-5 3,4,5 KIT 022 W/HKS Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886009062 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
Zenith™ Roth Composite Brackets (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™ EDGEWISE COMPOSITE BRACKET (KIT) — 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.
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 054e1bd1-0050-4686-bb05-36b5c39f5db3 35 fields · synced Jun 8, 2026