BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC
BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC (Florida): 510(k) cleared for ZimVie US Corp, LLC. Its amount of 185 is above the median of 138 (65th percentile). Dated 44 days ago, it serves as a historical benchmark. Score 53/100. 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: 185 · 65th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260940 |
| Device | BellaTek Bars |
| Applicant | ZimVie US Corp, LLC |
| Specialty / panel | Dental |
| Product code | NHA |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-03-20 |
| Decision date | 2026-09-21 |
| Review time (days) | 185 |
| Third-party review | No |
| Applicant location | Palm Beach Gardens, FL, US |
| amount percentile | 65th of 414 (median 138, 1.3x median) |
| Peer records CSV (16 FL 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: 2026-09-21
- 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: BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC's amount: 65th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
53 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 185-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 44 days ago.
What is the FDAPulse record for BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC in Florida?
BellaTek Bars (K260940) by ZimVie US Corp, LLC was cleared on 2026-09-21 after 185 days of review.
How does BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC compare to other Florida FDAPulse records?
Its amount of 185 sits in the upper half (65th percentile) of 414 records; the median is 138. It is 44 days old, still within a typical 45-day follow-up window.
BellaTek Bars (K260940) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BellaTek Bars (K260940) | FL | 2026-09-21 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
Compare BellaTek Bars (K260940) vs Yomi S Robotic System (K261321) →
Related records
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