Search Results
Found 1 results
510(k) Data Aggregation
K Number
K122748Device Name
ENGLER 25K SERIES ULTRASONIC INSERTS
Manufacturer
Date Cleared
2013-06-11
(277 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
ENGLER ENGINEERING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market.
This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1