FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquira
DI: 07898938244725
·
Model: 10 cases with 5 wax sticks each
·
Maquira Industria de Produtos Odontologicos S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Maquira
- Primary DI
- 07898938244725
- Version / Model
- 10 cases with 5 wax sticks each
- Catalog Number
- 80322409007
- Company Name
- Maquira Industria de Produtos Odontologicos S/A
- Labeler DUNS
- 679266866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-07
- Public Version
- 1
- Public Version Date
- 2024-08-15
- Public Version Status
- New
- Public Device Record Key
- d9c04321-93d2-4192-8739-b27e20201782
Device Description
The ORTHODONTIC WAX offers greater comfort in the use of fixed appliances, creating a barrier between the appliance and the lips, protecting them from mechanical shocks. The wax, when placed on the bracket, creates a protective barrier that avoids the discomfort of mechanical shocks that can cause small cuts on the lips.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGD | Wax, Dental, Intraoral | Dental | 872.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45251 | Orthodontic appliance relief material | A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898938244725 | GS1 |