ClearClub Impression Material (K261888): 510(k) cleared for ClearClub
ClearClub Impression Material (K261888): 510(k) cleared for ClearClub (California): 510(k) cleared for ClearClub. Its amount of 103 is below the median of 138 (36th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 103 · 36th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261888 |
| Device | ClearClub Impression Material |
| Applicant | ClearClub |
| Specialty / panel | Dental |
| Product code | SHI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-05 |
| Decision date | 2026-09-16 |
| Review time (days) | 103 |
| Third-party review | No |
| Applicant location | Inglewood, CA, US |
| amount percentile | 36th of 414 (median 138, 0.7x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: ClearClub Impression Material (K261888): 510(k) cleared for ClearClub and 76 California peers
- California FDAPulse records like this one: 76
- ClearClub Impression Material (K261888): 510(k) cleared for ClearClub's amount: 36th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 103-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for ClearClub Impression Material (K261888): 510(k) cleared for ClearClub in California?
ClearClub Impression Material (K261888) by ClearClub was cleared on 2026-09-16 after 103 days of review.
How does ClearClub Impression Material (K261888): 510(k) cleared for ClearClub compare to other California FDAPulse records?
Its amount of 103 is below the median (36th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
ClearClub Impression Material (K261888) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ClearClub Impression Material (K261888) | CA | 2026-09-16 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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