FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Splint
DI: D745COMSPL0
·
Model: COMSPL
·
Prismatik Dentalcraft, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Comfort Splint
- Primary DI
- D745COMSPL0
- Version / Model
- COMSPL
- Catalog Number
- COMSPL
- Company Name
- Prismatik Dentalcraft, Inc
- Labeler DUNS
- 022761689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-23
- Public Version
- 3
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- 18ee733a-abae-465e-92f2-db795ac12a7a
Device Description
Device to alleviate pain caused by bruxing or clenching of teeth
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 | D745COMSPL0 | HIBCC |
Customer Contacts
- Phone
- +1(800)854-7256
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121365 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius