Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC
Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC (California): 510(k) cleared for Sleepcare, LLC. Its amount of 96 is below the median of 138 (34th percentile). Dated 15 days ago, it is in the active follow-up window. Score 36/100. 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: 96 · 34th 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 | K262421 |
| Device | Daybreak Impression Material |
| Applicant | Sleepcare, LLC |
| Specialty / panel | Dental |
| Product code | SHI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-16 |
| Decision date | 2026-10-20 |
| Review time (days) | 96 |
| Third-party review | No |
| Applicant location | Los Angeles, CA, US |
| amount percentile | 34th 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: 2026-10-20
- 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: Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC and 76 California peers
- California FDAPulse records like this one: 76
- Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC's amount: 34th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 96-day review: this device is a strong predicate for similar products.
- Posted 15 days ago.
What is the FDAPulse record for Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC in California?
Daybreak Impression Material (K262421) by Sleepcare, LLC was cleared on 2026-10-20 after 96 days of review.
How does Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC compare to other California FDAPulse records?
Its amount of 96 is below the median (34th percentile); smaller records often move faster and face less competition. It is 15 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Daybreak Impression Material (K262421) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Daybreak Impression Material (K262421) | CA | 2026-10-20 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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