FDA product code SHI: Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
SHI is the FDA product code for impression material for fabrication of patient-matched mouthguards, over-the-counter. It is a Class II device, regulated under 21 CFR 872.3660 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under SHI, 3 in the last five years, from 3 different applicants. The average 510(k) review took 212 days (median 266); 212 days on average over the last three years.
Definition
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
| Field | Value |
|---|---|
| Device name | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter |
| Device class | Class II |
| Regulation | 21 CFR 872.3660 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for SHI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 3 | 212 |
Compare with all 510(k) review times · Search every SHI clearance
Top SHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ClearClub | 1 | 2026-09-16 |
| Encore Guards | 1 | 2026-03-17 |
| Grindguard, Inc. | 1 | 2026-02-25 |
Most recent SHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261888 | ClearClub | ClearClub Impression Material | 2026-09-16 | 103 |
| K251926 | Encore Guards | enCore Impression Material | 2026-03-17 | 267 |
| K251724 | Grindguard, Inc. | Remi Impression Material | 2026-02-25 | 266 |
Recalls for SHI devices
openFDA lists no recalls for product code SHI.
Frequently asked questions
What is FDA product code SHI?
SHI is the FDA product code for impression material for fabrication of patient-matched mouthguards, over-the-counter. It is a Class II device, regulated under 21 CFR 872.3660 and reviewed by the Dental panel.
What device class is SHI?
Class II, regulation 21 CFR 872.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHI?
Across 3 cleared submissions the average was 212 days from receipt to decision (median 266).
Which companies have the most SHI clearances?
ClearClub (1); Encore Guards (1); Grindguard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHI
- Run a recall and safety report across every SHI manufacturer
- Watch product code SHI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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