FDA UDI
In Commercial Distribution
🇺🇸 United States
Oral-B Nighttime Dental Guard
DI: D132MG0010
·
Model: 1
·
Oralabs, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Oral-B Nighttime Dental Guard
- Primary DI
- D132MG0010
- Version / Model
- 1
- Company Name
- Oralabs, LLC
- Labeler DUNS
- 801824756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-04
- Public Version
- 2
- Public Version Date
- 2023-08-17
- Public Version Status
- Update
- Public Device Record Key
- c8e9bc32-b499-4da6-bee1-89d11c7788fb
Device Description
Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OMR | Vessel Guard Or Cover | Cardiovascular | 870.3470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38621 | Mouthguard, reusable | A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D132MG0010 | HIBCC | ||||
| Secondary | 00728947000210 | GS1 |
Customer Contacts
- Phone
- 1-800-600-2861
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113326 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 dental guard to mold |