One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG
One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG: 510(k) cleared for Dent4You AG. Its amount of 1 is below the median of 138 (0th percentile). Dated 27 days ago, it is in the active follow-up window. Score 41/100. 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: 1 · 0th percentile of 414 FDAPulse records · 0.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263680 |
| Device | One Coat Bond; One Coat Bond SL |
| Applicant | Dent4You AG |
| Specialty / panel | Dental |
| Product code | KLE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-10-07 |
| Decision date | 2026-10-08 |
| Review time (days) | 1 |
| Third-party review | Yes |
| Applicant location | Heerbrugg, CH |
| amount percentile | 0th of 414 (median 138, 0.0x median) |
| Peer records CSV (7 CH records) | 🔒 Click to unlock → |
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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: 2026-10-08
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CH first): ErgoSteel (ES0001/696) (K253762) · DRIM-Nail System (K260115) · M-Vizion Femoral Revision System Extension (K260173) · CAS-One IR (K261225) · OTOPLAN (K262080) · Browse all by state and category →
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: One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG and 7 CH peers
- CH FDAPulse records like this one: 7
- One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG's amount: 0th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 1-day review: this device is a strong predicate for similar products.
- Reviewed through the third-party program.
- Posted 27 days ago.
What is the FDAPulse record for One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG?
One Coat Bond; One Coat Bond SL (K263680) by Dent4You AG was cleared on 2026-10-08 after 1 days of review.
How does One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG compare to other FDAPulse records?
Its amount of 1 is below the median (0th percentile); smaller records often move faster and face less competition. It is 27 days old, still within a typical 45-day follow-up window.
One Coat Bond; One Coat Bond SL (K263680) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| One Coat Bond; One Coat Bond SL (K263680) | CH | 2026-10-08 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Dental devices
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