FDA UDI
In Commercial Distribution
🇺🇸 United States
SOVA
DI: 00858286007646
·
Model: Aero
·
Akervall Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SOVA
- Primary DI
- 00858286007646
- Version / Model
- Aero
- Company Name
- Akervall Technologies, Inc.
- Labeler DUNS
- 023254296
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 2
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- 3624aa5b-29b2-4d20-b1b2-57eb8678d1e1
Device Description
SOVA Aero 1.6mm Ecommerce Packaging
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
- 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 |
|---|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46493 | Removable dental occlusal splint, customizable | A device intended for home-use intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858286007646 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121272 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 1.6 | Millimeter |