FDA UDI
In Commercial Distribution
🇺🇸 United States
VAPOR™ ROTH CERAMIC BRACKETS
DI: 10190886007686
·
Model: 75-U3-2RK-V
·
G & H Wire Company, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- VAPOR™ ROTH CERAMIC BRACKETS
- Primary DI
- 10190886007686
- Version / Model
- 75-U3-2RK-V
- Company Name
- G & H Wire Company, Inc.
- Labeler DUNS
- 831465641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- dc7e51fb-14c8-47c2-853e-e53fbef1e431
Device Description
VAPOR™ ROTH .022 UR3 HK 0°T +11°A 4°R 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58937 | Orthodontic bracket, ceramic | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190886007686 | GS1 | ||||
| Unit of Use | 00190886007689 | GS1 |
Customer Contacts
- Phone
- +1-317-346-6655
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132368 | 000 |