Device class
Class II
Regulation 872.3660
Total clearances
3
2026-02-25 → 2026-09-16
Definition
What is Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.
Classification details
Regulation number
872.3660
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Grindguard, Inc. |
1 |
1 |
2026-02-25 |
|
ClearClub |
1 |
1 |
2026-09-16 |
|
Encore Guards |
1 |
1 |
2026-03-17 |
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 |
| 99607 |
CPT
|
— |
Low
|
Over-the-counter impression material for patient-matched mouthguards is supply/device, not typically billed |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-16 |
K261888 |
ClearClub
|
ClearClub Impression Material |
| 2026-03-17 |
K251926 |
Encore Guards
|
enCore Impression Material |
| 2026-02-25 |
K251724 |
Grindguard, Inc.
|
Remi Impression Material |