OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.
OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.: 510(k) cleared for Spident Co., Ltd. Its amount of 89 is below the median of 138 (29th percentile). Dated 22 days ago, it is in the active follow-up window. Score 36/100. 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: 89 · 29th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262433 |
| Device | OrthoFit Aligner (OrthoFit Aligner A2) |
| Applicant | Spident Co., Ltd. |
| Specialty / panel | Dental |
| Product code | DYH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-16 |
| Decision date | 2026-10-13 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Incheon, KR |
| amount percentile | 29th of 414 (median 138, 0.6x 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: 2026-10-13
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (KR first): cCeLL405 (K254030) · ECG Analysis Software (AiTiALVSD) (K254302) · REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) · S-Patch CardioAI (K254255) · PicoreMax (PicoreMax) (K254199) · Browse all by state and category →
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: OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.'s amount: 29th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 89-day review: this device is a strong predicate for similar products.
- Posted 22 days ago.
What is the FDAPulse record for OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.?
OrthoFit Aligner (OrthoFit Aligner A2) (K262433) by Spident Co., Ltd. was cleared on 2026-10-13 after 89 days of review.
How does OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd. compare to other FDAPulse records?
Its amount of 89 is below the median (29th percentile); smaller records often move faster and face less competition. It is 22 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.
OrthoFit Aligner (OrthoFit Aligner A2) (K262433) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OrthoFit Aligner (OrthoFit Aligner A2) (K262433) | KR | 2026-10-13 |
| REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) | KR | 2026-09-25 |
| Dia-X Sil Light Body (K254152) | KR | 2026-09-16 |
| Dia-X Sil Heavy Body (K254142) | KR | 2026-09-16 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Dental devices
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