FDA UDI
In Commercial Distribution
🇺🇸 United States
Night Guard
DI: 00850073333013
·
Model: Printed Night Guard
·
3D DIAGNOSTIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Night Guard
- Primary DI
- 00850073333013
- Version / Model
- Printed Night Guard
- Company Name
- 3D DIAGNOSTIX, INC.
- Labeler DUNS
- 004512027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-11
- Public Version
- 1
- Public Version Date
- 2025-09-19
- Public Version Status
- New
- Public Device Record Key
- c15f02f1-151d-401e-b968-e8d815cdea3f
Device Description
Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| MQC | Mouthguard, Prescription | Unknown | U |
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 | 00850073333013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202465 | 000 |