510(k) clearances

iNOS intraoral biosensor

Achaemenid, LLC · Dental

K254304Substantially EquivalentTraditionalPLC
Open FDA's page for this record
Third party flag
N
City
Boston
Advisory committee description
Dental
Address 1
75 State St.
Address 2
Suite 100
Statement or summary
Summary
Product code
PLC
Zip code
02109
Applicant
Achaemenid, LLC
Decision date
2026-08-25
Decision code
SESE
Country code
US
Device name
iNOS intraoral biosensor
Advisory committee
DE
Contact
Reza Radmand
K number
K254304
State
MA
Date received
2025-12-31
Review advisory committee
DE
Postal code
02109
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Sleep Appliances With Patient Monitoring
Medical specialty description
Dental
Regulation number
872.5570
Device class
2
Registration number
3013116677, 3004748290, 3005343849, 3005598536, 3009440973, 3008186372, 1937100
FEI number
3013116677, 3004748290, 3005343849, 3005598536, 3009440973, 3008186372, 1937100
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.