Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K251597
Device Name InnerView System
Applicant
Perimetrics, Inc.
8441 154th Ave. NE
Bldg. H-210
Redmond,  WA  92056
Applicant Contact Alicia Mszyca
Correspondent
Perimetrics, Inc.
8441 154th Ave. NE
Bldg. H-210
Redmond,  WA  92056
Correspondent Contact Alicia Mszyca
Regulation Number872.4200
Classification Product Code
EKX  
Date Received05/27/2025
Decision Date 09/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-