Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE
Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE (Delaware): 510(k) cleared for Dürr Dental SE. Its amount of 87 is below the median of 138 (27th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, 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: 87 · 27th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262073 |
| Device | Hygienic Protective Bite Cover (2207-010-50) |
| Applicant | Dürr Dental SE |
| Specialty / panel | General, Plastic Surgery |
| Product code | PEM |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-09-17 |
| Review time (days) | 87 |
| Third-party review | No |
| Applicant location | Bietigheim-Bissingen, DE |
| amount percentile | 27th of 414 (median 138, 0.6x median) |
| Peer records CSV (25 DE 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: 2026-09-17
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE's amount: 27th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 87-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE in Delaware?
Hygienic Protective Bite Cover (2207-010-50) (K262073) by Dürr Dental SE was cleared on 2026-09-17 after 87 days of review.
How does Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE compare to other Delaware FDAPulse records?
Its amount of 87 is below the median (27th percentile); smaller records often move faster and face less competition. It is 48 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.
Hygienic Protective Bite Cover (2207-010-50) (K262073) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Hygienic Protective Bite Cover (2207-010-50) (K262073) | DE | 2026-09-17 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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