Identity
- Trade Name
- VAPOR™ MBT CERAMIC BRACKETS (KIT) FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- VAPOR™ MBT .022 HK/345 5 KIT Vapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded – (CIM) Manufacturing. They are translucent in appearance, and aesthetically pleasing. They have a revolutionary "Portal" Bonding Base; so adhesive flows through portals in the base for unprecedented mechanical bonds and optimal debonds. FDA UDI
- Model / Reference
- 76K-345-22-05 FDA UDI
- Description
- VAPOR™ MBT .022 HK/345 5 KIT Vapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded – (CIM) Manufacturing. They are translucent in appearance, and aesthetically pleasing. They have a revolutionary "Portal" Bonding Base; so adhesive flows through portals in the base for unprecedented mechanical bonds and optimal debonds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886010600 FDA UDI
- 510(k) Number
- K132368 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic 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, ceramic
Vapor™ Mbt Ceramic 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, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
- Ceramic/Metal Combination Kits — TP ORTHODONTICS, INC. · Class II
- TipEdge PLUS Ceramic Readi-Base Bracket — TP ORTHODONTICS, INC. · Class II
- Experience — GC Orthodontics America Inc. · Class II
- Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- EXPERIENCE® — GC Orthodontics America Inc. · Class II
- APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II
Cleared under the same submission
K132368 also covers:
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ MBT METAL-LINED CERAMIC BRACKETS (KIT) — G&H Wire Company, Inc.
- CLARION™ ROTH METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ ROTH METAL-LINED CERAMIC BRACKETS — G&H Wire Company, Inc.
- CLARION™ ROTH METAL-LINED CERAMIC BRACKETS (KIT) — G&H Wire Company, Inc.
- DIAMANTE™ MBT CERAMIC BRACKETS — G&H Wire Company, Inc.
- DIAMANTE™ ROTH CERAMIC 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI 6c7ea6ad-0b84-44e3-a620-af18b504fd35 35 fields · synced Jun 8, 2026