FDA UDI
In Commercial Distribution
🇺🇸 United States
KGuard Pro
DI: D866MOUTHGUARDG0
·
Model: MOUTHGUARD
·
Ortho-Tain, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KGuard Pro
- Primary DI
- D866MOUTHGUARDG0
- Version / Model
- MOUTHGUARD
- Catalog Number
- MOUTHGUARD-G
- Company Name
- Ortho-Tain, Inc
- Labeler DUNS
- 090557638
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- ab259aa3-90ea-4d61-b525-f4d0436df074
Device Description
MOUTHGUARD GREEN
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DYO | Band, Material, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35310 | Orthodontic retainer | An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D866MOUTHGUARDG0 | HIBCC |