Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262378

Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.

Q: How to monitor Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc. and peer dental records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.: 510(k) cleared for InnoDtech, Inc. Its amount of 86 is below the median of 138 (26th percentile). Dated 29 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 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 86 · 26th 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	K262378
Device	Dr.AlignNavi
Applicant	InnoDtech, Inc.
Specialty / panel	Dental
Product code	PNN
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-07-13
Decision date	2026-10-07
Review time (days)	86
Third-party review	No
Applicant location	Gwangju, KR
amount percentile	26th of 414 (median 138, 0.6x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-07
Data refreshed: 2026-11-04
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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: Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc. and 32 KR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

KR FDAPulse records like this one: 32
Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.'s amount: 26th 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 86-day review: this device is a strong predicate for similar products.
Posted 29 days ago.

What is the FDAPulse record for Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.?

Dr.AlignNavi (K262378) by InnoDtech, Inc. was cleared on 2026-10-07 after 86 days of review.

How does Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc. compare to other FDAPulse records?

Its amount of 86 is below the median (26th percentile); smaller records often move faster and face less competition. It is 29 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.

Dr.AlignNavi (K262378) vs. top 3 peers

Organization	Location	Record date
Dr.AlignNavi (K262378)	KR	2026-10-07
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

How to monitor Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc. and peer dental records

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