FDA product code SHQ: Dental Image Analyzer, In-Office
SHQ is the FDA product code for dental image analyzer, in-office. It is a Class II device, regulated under 21 CFR 872.1770 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under SHQ, 1 in the last five years. The average 510(k) review took 88 days (median 88); 88 days on average over the last three years.
Definition
A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions.
Classification
| Field | Value |
|---|---|
| Device name | Dental Image Analyzer, In-Office |
| Device class | Class II |
| Regulation | 21 CFR 872.1770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for SHQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 88 |
Compare with all 510(k) review times · Search every SHQ clearance
Top SHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3Shape TRIOS A/S | 1 | 2026-04-10 |
Most recent SHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260082 | 3Shape TRIOS A/S | TRIOS Dx (R1) | 2026-04-10 | 88 |
Recalls for SHQ devices
openFDA lists no recalls for product code SHQ.
Frequently asked questions
What is FDA product code SHQ?
SHQ is the FDA product code for dental image analyzer, in-office. It is a Class II device, regulated under 21 CFR 872.1770 and reviewed by the Dental panel.
What device class is SHQ?
Class II, regulation 21 CFR 872.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHQ?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most SHQ clearances?
3Shape TRIOS A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHQ
- Run a recall and safety report across every SHQ manufacturer
- Watch product code SHQ 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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