Device class
—
Regulation —
Total clearances
5
2020-01-28 → 2024-02-23
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Biotex, Inc.
|
1 |
0 |
2021-07-20 |
|
Aiomega, LLC |
1 |
0 |
2024-02-23 |
|
Advanced Facialdontics, LLC |
1 |
0 |
2020-01-28 |
|
Slow Wave, Inc. |
1 |
0 |
2020-10-02 |
|
Achaemenid, LLC |
1 |
0 |
2023-07-12 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 92510 |
CPT
|
— |
Low
|
Orthodontic procedure; comprehensive treatment of the adolescent dentition |
| D8999 |
HCPCS
|
— |
Low
|
Dental device/appliance not elsewhere classified |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-02-23 |
K233754 |
Aiomega, LLC
|
AIO Breathe |
| 2023-07-12 |
K230532 |
Achaemenid, LLC
|
RADx Intraoral Appliance for Snoring and Sleep Apnea |
| 2021-07-20 |
K203712 |
Biotex, Inc.
|
The Slide |
| 2020-10-02 |
K191320 |
Slow Wave, Inc.
|
Slow Wave DS8 |
| 2020-01-28 |
K192581 |
Advanced Facialdontics, LLC
|
The NightBlocks Appliance |