Device class
Class II
Regulation 872.1745
Total clearances
7
2020-07-02 → 2026-04-28
Classification details
Regulation number
872.1745
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
3Shape TRIOS A/S
|
2 |
0 |
2025-04-04 |
|
Smartooth Co., Ltd. |
1 |
0 |
2024-05-01 |
|
AIOBIO Co., Ltd. |
1 |
0 |
2024-09-04 |
|
Good Doctors Co., Ltd. |
1 |
0 |
2020-07-02 |
|
Zumax Medical Co., Ltd. |
1 |
1 |
2026-04-28 |
|
Sopro |
1 |
0 |
2023-12-14 |
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 |
| 99000 |
CPT
|
— |
Low
|
Caries detection laser; may be component of preventive exam or billed separately as diagnostic laser |
Pulse
Most recent 510(k) clearances